[Federal Register: September 28, 2009 (Volume 74, Number 186)]
[Notices]
[Page 49376]
[DOCID:fr28se09-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI09-13-000]

Clayton Silver Mines, Inc.; Notice of Petition for Declaratory
Order and Soliciting Comments, Protests, and/or Motions To Intervene

September 18, 2009.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Petition for Declaratory Order.
    b. Docket No: DI09-13-000.
    c. Date Filed: September 2, 2009.
    d. Applicant: Clayton Silver Mines, Inc.
    e. Name of Project: Clayton Silver Mine Hydro Project.
    f. Location: The Clayton Silver Mine Hydro Project is located on
Kinnikinic Creek, near Clayton, in Custer County, Idaho, affecting T.
11 N, R. 17 E, sec. 13, Boise Meridian.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Robert B. Corrigan, 59 N. Sierra View Way,
Eagle, ID 83622; telephone:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or E-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions: October
19, 2009.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, D.C. 20426. Comments, protests, and/or interventions may be
filed electronically via the Internet in lieu of paper. Any questions,
please contact the Secretary's Office. See, 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site at http://
www.ferc.gov under the ``e-Filing link.
    Please include the docket number (DI09-13-000) on any comments,
protests, and/or motions filed.
    k. Description of Project: The Clayton Silver Mines Hydro project
consists of: (1) A powerhouse containing a 600-kW Pelton wheel and
generator; (2) an 18-inch-diameter, 9,500-foot-long penstock; (3) a 15-
foot-long tailrace, emptying into Kinnikinic Creek; and (4) appurtenant
facilities. The proposed project will be connected to an interstate
grid. The project will not occupy federal lands.
    When a Petition for Declaratory Order is filed with the Federal
Energy Regulatory Commission, the Federal Power Act requires the
Commission to investigate and determine if the interests of interstate
or foreign commerce would be affected by the project. The Commission
also determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link, select ``Docket'' and follow the
instructions. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents -- Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-23284 Filed 9-25-09; 8:45 am]

BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

                                                                                OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	March 5, 2008

SUBJECT:	Cyazofamid: Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for a PMRA and IR-4 Proposed Section 3 Registration in/on Carrot Root.

PC Code:	085651			Decision Number: 381623

DP Number: 	343442

REVIEWER:	Amelia M. Acierto, Chemist

Registration Branch 3

Health Effects Division (7509P)

THROUGH:	Anant Parmar, Biologist

Sheila Piper, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Paula Deschamp, Branch Chief

Registration Branch 3

Health Effects Division (7509P)

TO:		Kelly O’Rourke, Risk Assessor

		Registration Action Branch 3

Health Effects Division (7509P)

and

Tony Kish/Janet Whitehurst

Fungicide Branch

Registration Division (7505P)

Executive Summary

ion 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.  The analyses were performed to support the proposed FIFRA §3 registration of the fungicide, cyazofamid, on carrot root.

Acute and chronic dietary risk assessments have been conducted previously for turf and ornamentals (D332427, Susan L. Stanton, 9/14/06).   For the purpose of the new use pattern,  HED has concluded that it would not be necessary to amend the previous dietary risk assessment except for the addition of the new food item (carrot) into the residue file.  This decision is based on the determination by the Environmental Effects Division that the maximum estimated Drinking Water Concentration (EDWCs) for parent cyazofamid and degradates CCIM, CCIM-AM and CTCA for the carrot use pattern in comparison to turf and ornamental use pattern, are much lower as values are 17% for the surface water acute, 5% for the surface water non-cancer chronic, and 7% for the cancer chronic.  Furthermore, the acute/chronic value for ground water is 25% of the values assigned for the turf and ornamentals use pattern. (D342613, Mohammed A. Ruhman, 2/21/08).

Therefore, the dietary risk assessment on carrot will be conducted using the same information and parameters used for the dietary risk assessment on turf and ornamentals.  The dietary and chronic exposure assessments will be performed on food + drinking water only.

The unrefined, Tier 1 acute and chronic analyses assumed that cyazofamid residues are present in all registered food commodities at tolerance levels and that 100% of all commodities are treated.  All processing factors were set to 1, based on the results of processing studies demonstrating that residues of cyazofamid in processed commodities would not exceed the raw agricultural commodity (RAC) tolerances.

Drinking water was incorporated directly into the dietary assessment using the estimated drinking water concentrations (EDWC) for the terminal degradate (CTCA) in surface water.  EDWCs were generated using the PRZM-EXAMS models.  For the acute assessment, the 1-in-10 year annual peak concentration of 136 ppb was used; for the chronic assessment, the 1-in-10 year annual mean value of 133 ppb was used.

Acute Dietary Exposure Results

The Tier 1 acute dietary exposure assessment was performed for females 13-49 years old only, since an acute endpoint of concern was not identified for the general U.S. population.  Based on the assumptions described above, acute dietary exposure of females 13-49 years old is well below HED’s level of concern at the 95th percentile of exposure.  Combined dietary exposure from food and drinking water is estimated at 0.009153 mg/kg/day, equivalent to <1% of the acute Population Adjusted Dose (aPAD).

Chronic Dietary Exposure Results

Chronic dietary exposure estimates for food and drinking water combined are also well below HED’s level of concern.  Using the DEEM-FCID software, dietary exposure is estimated at 0.003797 mg/kg/day for the general U.S. population (<1% of the chronic Population Adjusted Dose (cPAD) and 0.010691 mg/kg/day (1.1% of the cPAD) for infants <1 year old, the population subgroup with the highest estimated chronic dietary exposure to cyazofamid.

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 (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the reference dose (RfD) divided by the special Food Quality Protection Act (FQPA) Safety Factor.

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:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (8/20/99).

The most recent HED dietary risk assessment for cyazofamid (D332427, S. Stanton, 9/14/2006)

was conducted to support the FIFRA §3 registration on turf and ornaments.  As in the assessment

for turf and ornaments, this current assessment incorporates drinking water directly into the

dietary analyses.

II.	Food Residue Information

Residues of Concern:  The HED Metabolism Assessment Review Committee (MARC) concluded in a meeting on 2/18/04 that for the risk assessment and tolerance expression, parent and the metabolite designated as CCIM are the residues of concern for plant commodities.  The MARC also concluded that cyazofamid and the metabolites designated as CCIM, CCIM-AM and CTCA are considered to be the major residues in water and should be included in the drinking water risk assessment.  The current uses of cyazofamid fall under 40 CFR §180.6(a)(3) (i.e., there is no reasonable expectation of finite residues in livestock commodities).

Tolerances:  Tolerances have been established under 40 CFR §180.601 for the combined residues of  cyazofamid and its metabolite CCIM [4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile] in or on cucurbit vegetables (Group 9) (0.1 ppm), imported wine grapes (1.5 ppm), potato (0.02 ppm) and tomato (0.2 ppm).  Turf and ornamentals (non-food use sites) did not require establishment of additional tolerances.

Residue Data used for the Acute and Chronic Assessments:  The unrefined, Tier 1 acute and chronic analyses assumed that cyazofamid residues are present in/on all registered food commodities at tolerance levels and that 100% of all commodities are treated.  Adequate processing data are available for grapes (MRID 45409028), potatoes (MRID 45409033) and tomatoes (MRID 45409031).  The results of these studies indicate that residues in processed commodities will not exceed the raw agricultural commodity (RAC) tolerances (A. Acierto;

D285680; 2/20/04).  Therefore, all processing factors were set to 1x.   There were no processing data for carrot. The food residue data used in the acute and chronic analyses are summarized below in Table 1.

Table 1.  Residue Data used in the Acute and Chronic Dietary Analyses for Cyazofamid

Commodity	Tolerance	Percent Crop Treated	Processing Factors

Carrot, root	0.09 ppm	100	NA*

*Not applicable

 Drinking Water Data

Reference: Estimated Drinking Water Concentrations of Parent Cyazofamid and its Degradates CCIM, CCIM-AM and CTCA for Use in Human Health Risk Assessment (Turf and ornamentals use pattern); M. Ruhman; 9/6/06; DP Num: 319466).

The Environmental Effects Division determined that the maximum estimated Drinking Water Concentration (EDWCs) for parent cyazofamid and degradates CCIM, CCIM-AM and CTCA for the carrot use pattern in comparison to turf and ornamental use pattern, are much lower as values are 17% for the surface water acute, 5% for the surface water non-cancer chronic, and 7% for the cancer chronic.  Furthermore, the acute/chronic value for ground water is 25% of the values assigned for the turf and ornamentals use pattern. (DP Number 342613, Mohammed A. Ruhman, 2/21/08).  Therefore the EDWCs from EFED’s previous drinking water assessment for turf and ornamentals were used in this dietary assessment as described below.

The Environmental Fate and Effects Division (EFED) calculated screening level surface water and ground water estimates for cyazofamid and its degradates using linked PRZM/EXAMS models and the SCI-GROW model, respectively. The drinking water models and their descriptions are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .  Estimated drinking water concentrations (EDWCs) are presented in Table 2 for three scenarios as follows:

(1) 1st scenario (parent) assuming application of the maximum rate as parent;

(2) 2nd scenario (each of the degradates CCIM, CCIM-AM, and CTCA) assuming application of the molar equivalent of the parent for each of the degradate by apportioning the rate between the degradates based on molecular ratios and adjusted maximums found in fate studies; and

(3) 3rd scenario (the terminal degradate CTCA) assuming application of 100% molar conversions of the parent into this terminal degradate CTCA.

Table 2.  Resulting Maximum Surface/Ground water EDWCs for cyazofamid and each of its Major Degradates

Scenario	Chemical	Surface water EDWCs (ppb)	Ground water EDWC (ppb)

Acute

(1-in-10 yr. peak)	Chronic

 (1-in-10 yr. mean)

	1st  Scenario	Parent	14.362	0.377	0.01180

2nd  Scenario 	CCIM	17.106	12.094	0.00061

	CCIM-AM	6.699	6.312	0.00270

	CTCA	16.716	11.993	0.52300

3rd  Scenario 	CTCA	136.242	133.458	2.18000

The highest acute (peak) and chronic (mean) EDWCs were estimated for surface water using the PRZM/EXAMS model.  For the purpose of this Tier 1 dietary assessment, HED used the highest calculated screening EDWCs for surface water based on the 3rd modeling scenario: 136 ppb for the acute analysis and 133 ppb for the chronic analysis.  This approach may significantly overestimate dietary exposure to cyazofamid from drinking water; however, since estimated aggregate food and drinking water exposures using this approach are well below the acute and chronic levels of concern, additional refinements were not deemed necessary.  For both the a畣整愠摮挠牨湯捩愠慮祬敳ⱳ琠敨搠楲歮湩慷整⁲ 䑅䍗眠獡椠据牯潰慲整楤敲瑣祬愠⁳潰湩⁴獥楴慭 整椠桴䕄䵅愠慮祬楳⁳潴愠獳獥⁳硥潰畳敲琠祣 穡景浡摩映潲牤湩楫杮眠瑡牥മ†

IV.	DEEM-FCID™ Program and Consumption Information

Cyazofamid acute and chronic dietary exposure assessments were 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.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  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 most 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 dietary exposure assessments, 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 to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake 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

On February 10, 2004, the HIARC evaluated the toxicology database for cyazofamid with regard to the acute and chronic reference doses (RfDs).  The doses and toxicological endpoints selected for dietary exposure scenarios are summarized in Table 3.

.

Table 3.  Summary of Cyazofamid Toxicological Doses and Endpoints for Dietary Risk Assessment.

Exposure

Scenario

Dose Used in Risk Assessment, UF

FQPA SF and Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary

(Females 13-50 years of age)

NOAEL = 100 mg/kg

UF = 100

Acute RfD = 1.0 mg/kg

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

= 1.0 mg/kg

Rat Prenatal Developmental Toxicity (MRID 45408933)

LOAEL = 1,000 mg/kg based on developmental toxicity findings of increased incidence of bent ribs.

Acute Dietary

(General population including infants and children)

NOAEL = NA

UF = NA

Acute RfD = NA

FQPA SF =  NA

aPAD = acute RfD

              FQPA SF

= NA

Not Required.  No adverse effects were observed which could be attributed to a single-dose exposure.

Chronic Dietary

(All populations)

NOAEL= 94.8 mg/kg/day

UF = 100

Chronic RfD = 0.95

 mg/kg/day

FQPA SF = 1X

cPAD = chronic RfD

               FQPA SF

= 0.95 mg/kg/day

18-Month Mouse Oral Carcinogenicity (MRID 45408932)

LOAEL = 985 mg/kg/day based on increased skin lesions.

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, NA = Not Applicable

VI.	Results/Discussion

PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The acute exposure results are reported in Tables 4 and 5 for females 13-49 only.  The chronic results reported in Table 6 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.

Results of Acute Dietary Exposure Analysis

The Tier 1 acute dietary (food + drinking water) exposure assessment was performed for females 13-49 years old only, since an acute endpoint of concern was not identified for the general population.  Based on the assumptions described above in sections II and III, acute dietary exposure of females 13-49 years old is well below HED’s level of concern (i.e., <100% of the aPAD of 1.0 mg/kg).  The combined dietary exposure from food and drinking water is estimated at 0.009153 mg/kg/day (equivalent to <1% of the aPAD), at the 95th percentile of exposure, the appropriate regulatory statistic for Tier 1 dietary assessments.  It is noted that estimated acute dietary exposure of females 13-49 years old is also well below HED’s level of concern at the 99th ant 99.9th percentiles of exposure as shown in Table 4.

Table 4.  Results of Acute Dietary Exposure Analysis for Food and Drinking Water at the 95th Percentile of Exposure using DEEM FCID

Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile 99.9th Percentile

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

Females 13-49 years old 	1.0	0.009153	<1	0.015222	1.52	0.022308	2.2

Results of Chronic Dietary Exposure Analysis

-FCID™ software are well below HED’s level of concern for the general U.S. population and each of the population subgroups.  Dietary exposure was estimated at 0.003797 mg/kg/day for the U.S. population (<1% of the cPAD) and 0.010691 mg/kg/day (1.1% of the cPAD) for the most highly exposed population subgroup (infants <1 year old).  The estimated exposures/risks for food and drinking water are summarized in Table 5 for all populations.

Table 5.  Summary of Chronic Dietary Exposure and Risk for Cyazofamid1

Population Subgroup	    Exposure

(mg/kg/day)	% cPAD

General U.S. Population	0.003797	<1

All Infants (< 1 year old)1	0.010691	1.1

Children 1-2 years old	0.008923	<1

Children 3-5 years old	0.006946	<1

Children 6-12 years old	0.003992	<1

Youth 13-19 years old	0.002571	<1

Adults 20-49 years old	0.003284	<1

Adults 50+ years old	0.003500	<1

Females 13-49 years old	0.003307	<1

 1The population subgroup with the highest estimated chronic dietary (food + drinking water)

  exposure and  risk is indicated by bold text.

		     .

VII.	Characterization of Inputs/Outputs

These acute and chronic dietary exposure and risk estimates are conservative since they assume that 100% of crops are treated with cyazofamid and that residues are present at tolerance levels.  In addition, drinking water exposure estimates were based on screening level estimates generated by the PRZM-EXAMS model.  Dietary exposure estimates could be refined through the use of anticipated residues and percent crop treated data, as well as refined estimated drinking water concentrations.  However, since estimated exposures and risks using conservative assumptions are well below HED’s level of concern, such refinement is not warranted.

VIII.	Conclusions

These unrefined, Tier 1 dietary exposure analyses using DEEM-FCID™  indicate that acute and chronic dietary exposures to cyazofamid from food and drinking water are well below HED’s level of concern for this pesticide.  The estimated acute exposure of females 13-49 years old, the only population subgroup of concern for acute exposure, represents <1% of the aPAD at the 95th percentile of exposure.  Estimated chronic dietary exposures are less than or equal to 1.1% of the cPAD for the general U.S. population and all population subgroups.

IX.		List of Attachments

	Acute Food + Drinking Water Input File

	Acute Food + Drinking Water Results File

	Chronic Food + Drinking Water Input File

	Chronic Food + Drinking Water Results File

ACUTE FOOD + DRINKING WATER INPUT FILE

U.S. Environmental Protection Agency                                Ver. 2.02

DEEM-FCID Acute analysis for CYAZOFAMID

Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM.2008\acute cyazofamid food + water.R98

Analysis Date 03-06-2008            Residue file dated: 03-05-2008/15:08:44/8

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: Acute Food + Drinking Water using CTCA Drinking Water estimate (scenario #3): Females 13-49 only.

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

09020210 9B   Balsam pear                        0.100000   1.000  1.000

09010750 9A   Cantaloupe                         0.100000   1.000  1.000

01010780 1AB  Carrot                             0.090000   1.000  1.000

01010781 1AB  Carrot-babyfood                    0.090000   1.000  1.000

09010800 9A   Casaba                             0.100000   1.000  1.000

09020880 9B   Chayote, fruit                     0.100000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.100000   1.000  1.000

09021350 9B   Cucumber                           0.100000   1.000  1.000

95001750 O    Grape                              1.500000   1.000  1.000

95001760 O    Grape, juice                       1.500000   1.000  1.000

95001761 O    Grape, juice-babyfood              1.500000   1.000  1.000

95001770 O    Grape, leaves                      1.500000   1.000  1.000

95001780 O    Grape, raisin                      1.500000   1.000  1.000

95001790 O    Grape, wine and sherry             1.500000   1.000  1.000

09011870 9A   Honeydew melon                     0.100000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.020000   1.000  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   1.000  1.000

01032980 1C   Potato, flour                      0.020000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000

09023080 9B   Pumpkin                            0.100000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.100000   1.000  1.000

09023560 9B   Squash, summer                     0.100000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.100000   1.000  1.000

09023570 9B   Squash, winter                     0.100000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.100000   1.000  1.000

08003740 8    Tomatillo                          0.200000   1.000  1.000

08003750 8    Tomato                             0.200000   1.000  1.000

08003751 8    Tomato-babyfood                    0.200000   1.000  1.000

08003760 8    Tomato, paste                      0.200000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.200000   1.000  1.000

08003770 8    Tomato, puree                      0.200000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.200000   1.000  1.000

08003780 8    Tomato, dried                      0.200000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.200000   1.000  1.000

08003790 8    Tomato, juice                      0.200000   1.000  1.000

95003800 O    Tomato, Tree                       0.200000   1.000  1.000

86010000 O    Water, direct, all sources         0.136000   1.000  1.000

86020000 O    Water, indirect, all sources       0.136000   1.000  1.000

09013990 9A   Watermelon                         0.100000   1.000  1.000

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000

ACUTE FOOD + DRINKING WATER  RESULT FILE

U.S. Environmental Protection Agency                              Ver. 2.02

DEEM-FCID ACUTE Analysis for CYAZOFAMID                       (1994-98 data)

Residue file:acute cyazofamid food + water.R98 Adjustment factor #2 NOT used.

Analysis Date: 03-05-2008/15:10:28  Residue file dated: 03-05-2008/15:08:44/8

NOEL (Acute) = 100.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Acute Food + Drinking Water using CTCA Drinking Water estimate

scenario #3): Females 13-49 only."

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

Summary calculations:

      95th Percentile             99th Percentile             99.9th Percentile

 Exposure   aRfD     MOE     Exposure    aRfD     MOE    Exposure    aRfD      MOE

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

Seniors 55+:

  0.007968    0.80   12550    0.013217    1.32    7565    0.022816    2.28    4382

Children 1-2 yrs:

  0.029462    2.95    3394    0.058318    5.83    1714    0.166583   16.66     600

Children 3-5 yrs:

  0.020090    2.01    4977    0.039005    3.90    2563    0.077774    7.78    1285

Children 6-12 yrs:

  0.010952    1.10    9130    0.019358    1.94    5165    0.043834    4.38    2281

Youth 13-19 yrs:

  0.007340    0.73   13623    0.013031    1.30    7673    0.025155    2.52    3975

Adults 20-49 yrs:

  0.008756    0.88   11420    0.014869    1.49    6725    0.022728    2.27    4399

Adults 50+ yrs:

  0.007981    0.80   12529    0.013170    1.32    7593    0.022616    2.26    4421

Females 13-49 yrs:

  0.009153    0.92   10925    0.015222    1.52    6569    0.022308    2.23    4482

CHRONIC FOOD + DRINKING WATER INPUT FILE

Filename: C:\Documents and Settings\aacierto\Desktop\DEEM.2008\chronic cyazofamid food + water.R98

Chemical: cyazofamid

RfD(Chronic): .95 mg/kg bw/day  NOEL(Chronic): 94.8 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day  NOEL(Acute):  100 mg/kg bw/day

Date created/last modified: 03-05-2008/14:17:03/8          Program ver. 2.03

Comment: Chronic Food + Drinking Water using CTCA Drinking Water estimate (scenario #3)

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

09020210 9B   Balsam pear                        0.100000   1.000  1.000

09010750 9A   Cantaloupe                         0.100000   1.000  1.000

01010780 1AB  Carrot                             0.090000   1.000  1.000

01010781 1AB  Carrot-babyfood                    0.090000   1.000  1.000

09010800 9A   Casaba                             0.100000   1.000  1.000

09020880 9B   Chayote, fruit                     0.100000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.100000   1.000  1.000

09021350 9B   Cucumber                           0.100000   1.000  1.000

95001750 O    Grape                              1.500000   1.000  1.000

95001760 O    Grape, juice                       1.500000   1.000  1.000

95001761 O    Grape, juice-babyfood              1.500000   1.000  1.000

95001770 O    Grape, leaves                      1.500000   1.000  1.000

95001780 O    Grape, raisin                      1.500000   1.000  1.000

95001790 O    Grape, wine and sherry             1.500000   1.000  1.000

09011870 9A   Honeydew melon                     0.100000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.020000   1.000  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   1.000  1.000

01032980 1C   Potato, flour                      0.020000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000

09023080 9B   Pumpkin                            0.100000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.100000   1.000  1.000

09023560 9B   Squash, summer                     0.100000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.100000   1.000  1.000

09023570 9B   Squash, winter                     0.100000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.100000   1.000  1.000

08003740 8    Tomatillo                          0.200000   1.000  1.000

08003750 8    Tomato                             0.200000   1.000  1.000

08003751 8    Tomato-babyfood                    0.200000   1.000  1.000

08003760 8    Tomato, paste                      0.200000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.200000   1.000  1.000

08003770 8    Tomato, puree                      0.200000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.200000   1.000  1.000

08003780 8    Tomato, dried                      0.200000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.200000   1.000  1.000

08003790 8    Tomato, juice                      0.200000   1.000  1.000

95003800 O    Tomato, Tree                       0.200000   1.000  1.000

86010000 O    Water, direct, all sources         0.133000   1.000  1.000

86020000 O    Water, indirect, all sources       0.133000   1.000  1.000

09013990 9A   Watermelon                         0.100000   1.000  1.000

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000

CHRONIC FOOD + DRINKING WATER RESULT FILE

U.S. Environmental Protection Agency                             Ver. 2.00

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

Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM.2008\chronic cyazofamid food + water.R98                 Adjustment factor #2 NOT used.

Analysis Date 03-05-2008/14:48:32 Residue file dated: 03-05-2008/14:17:03/8

Reference dose (RfD, Chronic) = .95 mg/kg bw/day

NOEL (Chronic) = 94.8 mg/kg bw/day

COMMENT 1: Chronic Food + Drinking Water using CTCA Drinking Water estimate (scenario #3)

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of   Percent

           Subgroup                       body wt/day   Exposure 1/  of RfD

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

U.S. Population (total)                     0.003797       24,966        0.4%

U.S. Population (spring season)             0.003724       25,457        0.4%

U.S. Population (summer season)             0.004126       22,978        0.4%

U.S. Population (autumn season)             0.003653       25,954        0.4%

U.S. Population (winter season)             0.003682       25,746        0.4%

Northeast region                            0.003714       25,523        0.4%

Midwest region                              0.003816       24,844        0.4%

Southern region                             0.003529       26,865        0.4%

Western region                              0.004279       22,157        0.5%

Hispanics                                   0.004076       23,261        0.4%

Non-hispanic whites                         0.003777       25,101        0.4%

Non-hispanic blacks                         0.003519       26,940        0.4%

Non-hisp/non-white/non-black                0.004273       22,186        0.4%

All infants (< 1 year)                      0.010691        8,867        1.1%

Nursing infants                             0.004043       23,450        0.4%

Non-nursing infants                         0.013215        7,174        1.4%

Children 1-6  yrs                           0.007308       12,972        0.8%

Children 7-12 yrs     †††††††††††⸰〰㜳㈸†††㈠ⰵ㘰‷†† †〠㐮ഥ䘍浥污獥ㄠⴳ㤱⠠潮⁴牰来漠⁲畮獲湩⥧†† ††〠〮㈰㠵‰†††㘳㜬㔴††††⸰┳䘍浥污獥㈠ ⬰⠠潮⁴牰来漠⁲畮獲湩⥧†††††〠〮㌰㐵‸†† †㘲㜬㘱††††⸰┴

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Females 13-50 yrs                           0.003453       27,456        0.4%

Females 13+ (preg/not nursing)              0.003200       29,621        0.3%

Females 13+ (nursing)                       0.004541       20,877        0.5%

Males 13-19 yrs                             0.002546       37,232        0.3%

Males 20+ yrs                               0.003155       30,049        0.3%

Seniors 55+                                 0.003515       26,973        0.4%

Children 1-2 yrs                            0.008923       10,625        0.9%

Children 3-5 yrs                            0.006946       13,649        0.7%

Children 6-12 yrs                           0.003992       23,746        0.4%

Youth 13-19 yrs                             0.002571       36,876        0.3%

Adults 20-49 yrs                            0.003284       28,865        0.3%

Adults 50+ yrs                              0.003500       27,083        0.4%

Females 13-49 yrs                           0.003307       28,664        0.3%

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

Cyazofamid Dietary Exposure Assessment		DP Number: 343442			PC Code: 085651

________________________________________________________________________ ____________________ൟ


[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Proposed Rules]
[Pages 74737-74738]
[FR Doc No: 2015-30271]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 801, and 1100

[Docket No. FDA-2015-N-2002]
RIN 0910-AH19

Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments to
Regulations Regarding ``Intended Uses''; Reopening of the Comment
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the notice of proposed rulemaking (NPRM) that
appeared in the Federal Register of September 25, 2015. In the NPRM,
FDA requested comments on the proposed regulation that describes the
circumstances in which a product made or derived from tobacco that is
intended for human consumption will be subject to regulation as a drug,
device, or a combination product under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). The Agency is taking this action in
response to a request for an extension to allow interested persons
additional time to submit comments.

DATES: The comment period for the proposed rule published on September
25, 2015 (80 FR 57756) is extended. Submit either electronic or written
comments by December 30, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-2002 for this rulemaking. Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential

information that you do not wish to be made publicly available, submit
your comments only as a written/paper submission. You should submit two
copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on http://www.regulations.gov. Submit both copies to the
Division of Dockets Management. If you do not wish your name and
contact information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryant Godfrey or Darin Achilles,
Office of Regulations, Center for Tobacco Products, Food and Drug
Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002,
877-287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of September 25,
2015 (80 FR 57756), FDA proposed a regulation that describes the
circumstances in which a product made or derived from tobacco that is
intended for human consumption will be subject to regulation as a drug,
device, or a combination product under the FD&C Act. Interested persons
were originally given until November 24, 2015, to comment on the NPRM.
    The Agency has received a request for a 45-day extension of the
comment period for the NPRM. The request conveyed concern that the
current 60-day comment period does not allow sufficient time to develop
a meaningful or thoughtful response to the NPRM.
    FDA has considered the request and is reopening the comment period
for the NPRM for 30 days, until December 30, 2015. The Agency believes
that reopening the comment period for an additional 30 days allows
adequate time for interested persons to submit comments without
significantly delaying rulemaking on these important issues.

    Dated: November 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-30271 Filed 11-27-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Notices]
[Page 71271]
[FR Doc No: 2021-27056]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0505]

Julia Fees: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Julia Fees for a period of 5 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Ms. Fees was convicted of one felony count under Federal
law for conspiracy to commit offenses against the United States. The
factual basis supporting Ms. Fees' conviction, as described below, is
conduct relating to the importation into the United States of a drug or
controlled substance. Ms. Fees was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
she should not be debarred. As of September 12, 2021 (30 days after
receipt of the notice), Ms. Fees had not responded. Ms. Fees' failure
to respond and request a hearing constitutes a waiver of her right to a
hearing concerning this matter.

DATES: This order is applicable December 15, 2021.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any drug or controlled substance.
    On May 5, 2021, Ms. Fees was convicted, as defined in section
306(l)(1) of FD&C Act, in the U.S. District Court for the Western
District of Pennsylvania, when the court entered judgment against her
for the offense of conspiracy to commit offenses against the United
States, in violation of 18 U.S.C. 2 and 371. FDA's finding that
debarment is appropriate is based on the felony conviction referenced
herein.
    The factual basis for this conviction is as follows: As contained
in the indictment in Ms. Fees' case, filed August 22, 2017, to which
she plead guilty, from on or about April 2015 and continuing until May
2017, Ms. Fees was involved in the operation of a website,
www.etizy.com, through which she sold and distributed a drug known as
etizolam to consumers throughout the United States. Etizolam is a drug
known as thienodiazepine, which is chemically similar to
benzodiazepines and carries risks of dependency, toxicity, and the
possibility of fatal overdose. Etizolam is not FDA-approved in the
United States. Ms. Fees and her co-conspirator illegally bought
etizolam from an overseas supplier in India, which she then arranged to
have smuggled into the United States through the use of multiple post
office boxes controlled by her and her co-conspirator. To avoid Federal
regulators, she used false and misleading labeling and generally
misrepresented the nature of the products sold on the website she
operated. Ms. Fees reshipped the misbranded etizolam to customers
located in the United States.
    As a result of this conviction, FDA sent Ms. Fees, by certified
mail, on August 3, 2021, a notice proposing to debar her for a 5-year
period from importing or offering for import any drug into the United
States. The proposal was based on a finding under section 306(b)(3)(C)
of the FD&C Act that Ms. Fees' felony conviction under Federal law for
conspiracy to commit offenses against the United States, in violation
of 18 U.S.C. 371, was for conduct relating to the importation into the
United States of any drug or controlled substance because she illegally
imported, relabeled, and then introduced unapproved etizolam products
into interstate commerce. In proposing a debarment period, FDA weighed
the considerations set forth in section 306(c)(3) of the FD&C Act that
it considered applicable to Ms. Fees' offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.
    The proposal informed Ms. Fees of the proposed debarment and
offered her an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Fees received the proposal and notice of opportunity for a
hearing on August 13, 2021. Ms. Fees failed to request a hearing within
the timeframe prescribed by regulation and has, therefore, waived her
opportunity for a hearing and waived any contentions concerning her
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms. Julia
Fees has been convicted of a felony under Federal law for conduct
relating to the importation into the United States of any drug or
controlled substance. FDA finds that the offense should be accorded a
debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of
the FD&C Act.
    As a result of the foregoing finding, Ms. Fees is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Ms. Fees is a prohibited
act.
    Any application by Ms. Fees for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0505 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27056 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 24, 2010 (Volume 75, Number 226)]
[Notices]
[Page 71783-71785]
[DOCID:fr24no10-145]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63335; File No. SR-EDGA-2010-18]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing of Proposed Rule Change To Amend EDGA Rules 11.9(b)(1)(C) and
11.5(c)(7) Regarding Step-Up Orders

November 18, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 8, 2010, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
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\ 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 EDGA Rule 11.9(b)(1)(C) regarding
the description of the Step-up order type. The Exchange also proposes
to introduce Rule 11.5(c)(7) to allow Mid-Point Match orders entered in
response to Step-up orders to be processed pursuant to Rule
11.9(b)(1)(C).). The text of the proposed rule change is available on
the Exchange's Internet Web site at http://www.directedge.com, 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 self-regulatory organization 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Exchange Rule 11.5(c)(11) defines a Step-up order as a ``market or
limit order with the instruction that the System display the order to
Users at or within the NBBO price pursuant to Rule 11.9(b)(1)(C).''
Exchange Rule 11.9(b)(1)(C), in turn, states that orders shall be
displayed to Users \3\ (hereinafter referred to as ``Members''),\4\ in
a manner that is separately identifiable from other Exchange orders, at
or within the NBBO price for a period of time not to exceed five
hundred milliseconds as determined by the Exchange (the ``Step-up
Display Period).'' The Step-up Display Period is currently set at 25
milliseconds.
---------------------------------------------------------------------------

    \3\ Exchange Rule 11.9(b)(1) provides that (prior to display of
an order to a User), an incoming order shall first attempt to be
matched for execution against orders in the EDGA Book.
    \4\ Exchange Rule 1.5(cc) defines a User as ``any Member or
Sponsored Participant who is authorized to obtain access to the
System pursuant to Rule 11.3.''
---------------------------------------------------------------------------

    The Exchange proposes to amend Rule 11.9(b)(1)(C) to add language
to the rule text which will provide that at the conclusion of the Step-
up Display Period, the Step-up order shall execute against responsive
User orders priced at or within the NBBO, prevailing at the end of the
Step-up Display Period on a price/time priority basis consistent with
Rule 11.8(a)(1) and (2). Rules 11.8(a)(1) and (2), in turn, provide
that orders of Users shall be ranked and maintained in the EDGA Book
based on the following priority: (i) The highest-priced order to buy
(or lowest-priced order to sell) shall have priority over all other
orders to buy (or orders to sell); (ii) where orders to buy (or sell)
are made at the same price, the order clearly established as the first
entered into the System at such particular price shall have precedence
at that price, up to the number of shares of stock specified in the
order. Commencing on the six month anniversary of {Insert Commission
approval date of this rule filing{time} , the orders eligible for
executing against Step-up orders shall be expanded to include User
orders priced better but not outside the NBBO at the end of the Step-up
Display Period (such orders, ``Eligible Book Orders'').
    In effect, Step-up orders permit a Member to initiate a price
auction of such orders by displaying order solicitation information to
other Members simultaneously, provided such other Members have elected
to receive such order information (each such Member, an ``Electing
Member.''). After the passage of the Step-up Display Period, the Step-
up orders are executed against responses and, commencing on the six
month anniversary of {Insert Commission approval date of this rule
filing{time} , Eligible Book Orders, on a price/time priority basis in
accordance with Rule 11.8(a)(1) and (2). Responses are accumulated for
the Step-up Display Period by the Exchange, rather than processed at
arrival time. Eligible Book Orders will continue to be eligible for
execution against the EDGA Book during the Step-up Display Period.
    For example, assume the NBBO (national best bid/offer) is 10.10 x
10.12. If Member A enters a Step-up order to buy 500 shares of ABC
security at the prevailing national best offer ($10.12) and such Step-
up order cannot execute against the EDGA Book, then Electing Members
will receive a solicitation to sell 500 shares of ABC security at
$10.12 or lower. If Electing Members X, Y, and Z transmit an order to
sell 500 shares (or less) of ABC security at the prevailing national
best offer or lower (i.e., $10.12 or lower), within the Step-up Display
Period, they would all participate in a price auction, which would be
awarded at the end of the Step-up Display Period on a price/time
priority basis based on the prevailing NBBO at the end of such time
period. Therefore, if EDGA receives an order to sell 500 shares at
$10.11 from Electing Member X, then receives an order to sell 200
shares at $10.10 from Electing Member Y and lastly receives an order to
sell 200 shares at $10.11 from Electing Member Z, Electing Member Y
would have priority over Electing Members X and Z based on price
priority, assuming that such orders were received within the Step-up
Display Period. As a result, Electing Member Y's order would execute

against Member A's Step-up order for 200 shares at $10.10. The
remaining 300 shares would be awarded to Electing Member X at $10.11,
since Electing Member X has time priority over Electing Member Z.
Following the six month anniversary of {Insert Commission approval date
of this rule filing{time} , if non-electing Member W had an order to
sell 500 shares at $10.11 that was entered before Electing Member X's
order and it was not otherwise executed on the EDGX Book prior to the
end of the Step-up Display Period, then the remaining 300 shares in the
above example would be executed against Member W's order, since Member
W would have time priority over both Electing Members X and Z.
    The Exchange believes that this proposed amendment provides more
transparency regarding the timing associated with the price auction.
    The Exchange also proposes to add a new order type as Rule
11.5(c)(7) to allow Mid-Point Match orders that are entered in response
to Step-up orders to be eligible for execution pursuant to Rule
11.9(b)(1)(C), as described above. As proposed, the Mid-Point Match
order would be ``an order with an instruction to execute it at the
midpoint of the NBBO.'' This order type differs from the Mid-Point Peg
order in that it can only be used in response to a Step-up order type,
whereas the Mid-Point Peg order can be entered as a limit order but
cannot be used in response to a Step-up order. Further, the Mid-Point
Peg order can execute at a price better than the midpoint of the NBBO,
while the Mid-Point Match order will be time-stamped and priced at the
end of the Step-up Display Period.
    In response to the price auction described above, the Exchange will
not accept orders priced in subpennies. The respondent User could enter
a Mid-Point Match order, however, that would be eligible for execution
at the midpoint of the prevailing NBBO at the end of the Step-up
Display Period.
    The Exchange believes the midpoint response described above will
provide an additional pricing mechanism for the respondent User that is
willing to offer price improvement, but is unwilling to cross the
spread between the national best bid and offer to do so. By providing
this option, the Exchange believes that a greater proportion of Step-up
orders will receive price improvement. In addition, because the
midpoint response will execute all trades at the midpoint of the NBBO,
it will never execute a trade outside of the NBBO. If the national best
bid for a security underlying a Step-up order equals or ``locks'' the
national best offer for such security, a Mid-Point Match order response
will execute all trades at the locked price.
    The Step-up order process will not generate an execution if the
national best bid (offer) for the security underlying a Step-up order
is priced better than or ``crosses'' the national best offer (bid) for
such security. In the event of a ``crossed'' market or an absence of
responsive User orders at or within the NBBO and, commencing on the six
month anniversary of {Insert Commission approval date of this rule
filing{time} , Eligible Book Orders at the end of the Step-up Display
Period, the Step-up process shall terminate and the Step-up order shall
be cancelled or routed in accordance with the User's instructions.
Other Technical Amendments
    The Exchange proposes to make conforming changes to the numbering
of current rules 11.5(c)(7)-(14) to (c)(8)-(15) as a result of the
insertion of the Mid-Point Match order type in Rule 11.5(c)(7), as
described above. Similarly, the references to the newly numbered rules
are also proposed to be amended in Rule 11.5(c) and Rule 11.8(a)(2)(C).
2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Securities Exchange Act of 1934 (the ``Act''),\5\ which requires
the rules of an exchange to promote just and equitable principles of
trade, to remove impediments to and perfect the mechanism of a free and
open market and a national market system and, in general, to protect
investors and the public interest. The proposed rule change also is
designed to support the principles of Section 11A(a)(1) \6\ of the Act
in that it seeks to assure fair competition among brokers and dealers
and among exchange markets. The Exchange believes that the proposed
rule meets these requirements in that it seeks to promote the efficient
execution of investor transactions, and thus investor confidence, over
the long term by providing additional transparency relating to the
execution of Step-up orders.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b)(5).
    \6\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

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

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

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2010-18 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EDGA-2010-18. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission,\7\ 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, on official business days between the hours of 10 a.m.
and 3 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; 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-EDGA-2010-18 and should be
submitted on or before December 15, 2010.
---------------------------------------------------------------------------

    \7\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov/rules/sro.shtml.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-29590 Filed 11-23-10; 8:45 am]
BILLING CODE 8011-01-P


Rich Mason/RTP/USEPA/US

10/23/2007 11:53 AM

To

Janet Cakir/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA

cc

David Misenheimer/RTP/USEPA/US@EPA

Subject

Fw: origin of BELD3 land use data?

----- Forwarded by Rich Mason/RTP/USEPA/US on 10/23/2007 11:51 AM -----

Chris Geron/RTP/USEPA/US

10/23/2007 09:46 AM

To

Rich Mason/RTP/USEPA/US@EPA

cc

Subject

Re: origin of BELD3 land use data?

Rich,

We're in the process of updating some of the data and a draft paper describing it.

Attached is the draft as it is now.....

Chris Geron

Senior Scientist

U.S. Environmental Protection Agency

National Risk Management Research Laboratory

Mail Drop E305-02,  109 TW Alexander Dr.

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>

<EMAIL_ADDRESS> for FEDEX, UPS, Airborne other shipping:

4930 Old Page rd

Room D366

RTP, NC 27709

Rich Mason/RTP/USEPA/US

10/22/2007 11:30 AM

To

Chris Geron/RTP/USEPA/US@EPA

cc

Subject

origin of BELD3 land use data?

Hi Chris,

As part of a regulatory impact analysis workshop last week, I was asked about the "vintage" of the BELD3 land use data we used for biogenic emissions.  Can you point me to a reference for this data?

From what I can tell. there is updated biogenics land use data (which we were not aware of), as this BELD3 data appears to be 1990's in origin:

http://www.epa.gov/asmdnerl/biogen.html

http://www.epa.gov/asmdnerl/images/beld3_web.gif

Any information you can send would be great.  Thanks!

_____________________________________________

Rich Mason

Physical Scientist

Emission Inventory Analysis Group

U.S. Environmental Protection Agency

Mail Drop C339-02,109 TW Alexander Dr., RTP,NC 27711

(919) 541-3405 ( fax: -0684)


[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46288-46289]
[FR Doc No: 2014-18634]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72739; File No. SR-ISEGemini-2014-15]

Self-Regulatory Organizations; ISE Gemini, LLC; Order Approving
Proposed Rule Change on Bid/Offer Differentials for In-The-Money Option
Series

August 1, 2014.

I. Introduction

    On June 4, 2014, the ISE Gemini, LLC (``ISE Gemini'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act

of 1934 (``Act'')\1\ and Rule 19b-4 thereunder,\2\ a proposed rule
change to amend its rules to require that market makers quoting certain
in-the-money options series maintain quotes that are no wider than the
spread between the national best bid and offer (``NBBO'') in the
underlying security. The proposed rule change was published for comment
in the Federal Register on June 20, 2014.\3\ The Commission received no
comment letters on the proposed rule change. This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 72398 (June 16,
2014), 79 FR 35397 (June 20, 2014) (``Notice'').
---------------------------------------------------------------------------

II. Description

    ISE Gemini Rule 803(b)(4)(i) presently permits market makers to
submit quotes with wider bid/offer differentials for in-the-money
options series where the market for the underlying security is wider
than the market maker's regular quotation requirements. In particular,
a market maker quoting an in-the-money options series may submit quotes
that are as wide as the quotation on the primary market of the
underlying security.
    ISE Gemini proposes to change this obligation to instead require
that market makers quoting these in-the-money options series maintain
quotes that are no wider than the spread between the NBBO in the
underlying security. ISE Gemini believes that measuring the permissible
width of a market maker's quote against the NBBO more accurately
reflects the current trading environment where multiple trading venues
contribute to the prevailing market price of a security underlying an
options series traded on ISE Gemini. Further, ISE Gemini explains that
a market maker quoting an in-the-money options series can hedge its
position by trading in the underlying security at the NBBO, which may
be narrower than the quotation on the primary market. In addition, ISE
Gemini believes that requiring market makers to post tighter quotes
will improve market quality.

III. Discussion and Commission Findings

    After carefully considering the proposal, the Commission finds that
the proposed rule change is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\4\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\5\
which requires, among other things, that the rules of a national
securities exchange be designed to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The Commission notes that the proposal should improve
market quality by narrowing spreads to the benefit of investors.
---------------------------------------------------------------------------

    \4\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-ISEGemini-2014-15), be, and hereby
is, approved.
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-18634 Filed 8-6-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 17, 2005 (Volume 70, Number 199)]
[Notices]
[Page 60317-60318]
[DOCID:fr17oc05-59]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-5-000]

Natural Gas Pipeline Company of America; Notice of Revenue
Crediting Report

October 6, 2005.
    Take notice that on October 5, 2005, Natural Gas Pipeline Company
of America (Natural) filed its Refund Report regarding the penalty
revenues for the period January 1, 2005 through June 30, 2005 that it
refunded to its customers pursuant to Section 12.8 of the General Terms
and Conditions (GT&C) of its FERC Gas Tariff, Sixth Revised Volume No.
1.
    Natural states that the purpose of this filing is to inform the
Commission of its refund to customers of penalty revenue pursuant to
Section 12.8 of Natural's GT&C.
    Natural states that copies of the filing are being mailed to its
customers and interested state commissions.
    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 on or before the

date as indicated below. 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>.
    Comment Date: 5 p.m. Eastern Time October 14, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5680 Filed 10-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 20, 2007 (Volume 72, Number 76)]
[Notices]
[Page 19914-19915]
[DOCID:fr20ap07-45]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-398-000]

Cheyenne Plains Gas Pipeline Company, LLC; Notice of Tariff
Filing

April 13, 2007.
    Take notice that on April 12, 2007, Cheyenne Plains Gas Pipeline
Company, L.L.C. (Cheyenne Plains) tendered for filing as part of its
FERC Gas Tariff, Original Volume No. 1, Sixth Revised Sheet No. 1 to
become effective May 13, 2007.
    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>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-7573 Filed 4-19-07; 8:45 am]

BILLING CODE 6717-01-P


IMPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, OARM, OAM 2. OMB control number b. G None a 2030  0006 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Invitation for Bids and Request for Proposals ( IFBs and RFPs)

8. Agency form number( s) ( If applicable)

9. Keywords Procurement, Government 10. Abstract Firms which are interested in providing supplies and services to EPA will furnish information in previous contracts performed, technical information, and cost or pricing information. They will submit this information when the Agency announces a need for supplies or services which they are capable of providing. EPA will use this information to determine which firm's offer is most suited to the Agency's requirement.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. X Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. P Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1261 b. Total annual responses 1261 1. Percentage of these responses collected electronically 0 % c. Total hours requested 246,527 d. Current OMB inventory 399,342 e. Difference  152,815 f. Explanation of difference 1. Program Change 2. Adjustment  152,815 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. P _ Application for benefits e._ Program planning or management b. Program evaluation f. Research c. __ General purpose statistics g. Regulatory or compliance d. Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Leigh Pomponio Phone: ( 202) 564 4364 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Thomas D. McEntegart, Manager Policy Service Center Office of Acquisition Management Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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 83 I ( Instructions) 10/ 95