[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Page 13979]
[FR Doc No: 2018-06577]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14869-000]

Notice of Preliminary Permit Application Accepted for Filing and
Soliciting Comments, Motions To Intervene, and Competing Applications;
RAMM Power Group, LLC

    On February 28, 2018, RAMM Power Group LLC, filed an application
for a preliminary permit, pursuant to section 4(f) of the Federal Power
Act (FPA), proposing to study the feasibility of the Sacaton Energy
Storage Project (Sacaton Project or project), a closed-loop pumped
storage project to be located in Pinal County, Arizona. The sole
purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project would consist of the following new facilities:
(1) A 28-foot-high dam with a total crest length of 6,000 feet,
creating a 1,300 acre-foot upper reservoir with a maximum surface
elevation of 1,456 feet mean sea level (MSL); (2) a 200-foot-long, 12-
foot-diameter steel penstock extending from the upper reservoir dam to
the powerhouse; (3) an underground powerhouse with two 75-megawatt
pump/turbine units; (4) a 2,200-foot-long, 14-foot-diameter low
pressure draft tube extending from the powerhouse to the lower
reservoir; (5) a 1,500 acre-foot lower reservoir with a maximum
reservoir surface elevation of 455 feet MSL to be located within an
existing pit mine (no dam needed); (6) a new 200-Megavolt-ampere
substation located adjacent to the upper reservoir; (7) a 2,500-foot-
long, 137-kilovolt (kV) transmission line extending from the project's
substation to existing 137-kV transmission lines owned by Arizona
Public Service; and (8) appurtenant facilities. The estimated average
annual generation of the Sacaton Project would be 400,000 megawatt-
hours
    Applicant Contact: Dr. Michael A. Werner, RAMM Power Group, 7425
East Columbia Drive, Spokane, Washington 99212; phone:<PHONE_NUMBER>.
    FERC Contact: Khatoon Melick,<PHONE_NUMBER>,
[email protected].
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 Days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE,
Washington, DC 20426. The first page of any filing should include
docket number P-14869-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14869) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: March 26, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-06577 Filed 3-30-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 23, 2008 (Volume 73, Number 247)]
[Notices]
[Page 78790-78791]
[DOCID:fr23de08-81]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8756-1]

Notice of Availability of Preliminary Residual Designation of
Certain Stormwater Discharges in the State of Massachusetts Under the
National Pollutant Discharge Elimination System of the Clean Water Act

AGENCY: Environmental Protection Agency.

ACTION: Notice and Request for Public Comment.

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SUMMARY: The Regional Administrator of the Environmental Protection
Agency's (EPA) New England Regional Office is providing notice of the
availability of a preliminary determination that certain stormwater
discharges in the Charles River watershed located in Bellingham,
Milford, and Franklin, Massachusetts will be required to obtain permit
coverage under the National Pollutant Discharge Elimination System
(NPDES) of the Clean Water Act. EPA is seeking public comment on the
nature and scope of this preliminary residual designation. The period
for comment on this preliminary residual designation will remain open
until the close of the public comment period on any NPDES general or
individual permit related to this preliminary residual designation.
However, EPA strongly encourages interested parties to submit their
comments within 45 days of the commencement of the comment period,
after which EPA intends to review this preliminary residual designation
and to decide whether to make any changes to it. It is EPA's intention
to make a final residual designation following the close of the comment
period on any associated NPDES permit. Copies of the preliminary
residual designation are available for inspection online and in
hardcopy as described elsewhere in this document.

DATES: Comments must be submitted on or before February 6, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OW-2008-0857 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail and hand delivery: U.S. Environmental Protection
Agency, New England Region, One Congress Street, Suite 1100, Mailcode
CWN, Boston, MA 02114-2023. Deliveries are only accepted during the
Regional Office's normal hours of operation (8 a.m. to 5 p.m., Monday
through Friday, excluding legal holidays), and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OW-
2008-0857. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov, or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, New England Region, One Congress Street, Suite 1100,
Boston, Massachusetts. Such deliveries are only accepted during the
Regional Office's normal hours of operation, and special arrangements
should be made for deliveries of boxed information. To inspect the hard
copy materials, please schedule an appointment during normal

business hours with the contact listed in the FOR FURTHER INFORMATION
CONTACT section.

FOR FURTHER INFORMATION CONTACT: Erik Beck, EPA New England Region, One
Congress Street, Suite 1100, Mailcode CWN,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The Regional Administrator of EPA's New England Regional Office is
providing notice of availability of a preliminary determination that
certain stormwater discharges in the Charles River watershed located in
Bellingham, Milford, and Franklin, Massachusetts will be required to
obtain NPDES permits. Under Clean Water Act (CWA) Section 402(p) (33
U.S.C. 1342(p)), Congress required the EPA to establish permitting
requirements for certain stormwater discharges. In addition, CWA
Sections 402(p)(2)(E) and 402(p)(6) and implementing regulations at 40
CFR 122.26 (a)(9)(i)(C) and (D) provide that the EPA Regional
Administrator may designate additional stormwater discharges as
requiring NPDES permits where he determines that:
    1. Stormwater controls are needed for the discharge based on
wasteload allocations that are part of ``total maximum daily loads''
that address the pollutant of concern (in this case phosphorus), or
    2. The discharge, or category of discharges within a geographic
area, contributes to a violation of a water quality standard or is a
significant contributor of pollutants to waters of the United States.
    The EPA Regional Administrator for the New England Region has made
a preliminary determination pursuant to Section 402(p) of the Clean
Water Act and 40 CFR 122.26 (9)(i)(C) and (D) that stormwater controls
and NPDES permits are needed for discharges to waters of the United
States from impervious surfaces equal to or greater than two acres,
with certain exceptions, in the Charles River watershed located in
Bellingham, Milford, and Franklin, Massachusetts. Details on these
exceptions, as well as other details of the preliminary determination,
are available in the preliminary residual designation document. This
document and ancillary materials may be viewed on the EPA New England
Regional Office's Web page pertaining to excessive nutrients in the
Charles River, http://www.epa.gov/region1/charles/tmdl.html and at
http://www.regulations.gov.

    Dated: December 12, 2008.
Robert W. Varney,
Regional Administrator, EPA New England.
 [FR Doc. E8-30540 Filed 12-22-08; 8:45 am]

BILLING CODE 6560-50-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	24- MAY-2007

SUBJECT:	Thiabendazole Acute and Chronic Dietary Exposure and Risk Assessments to Support a Threshold of Regulation Decision for the Use of Thiabendazole as a Seed Treatment on Dry Pea.

PC Code:  060101			Decision Number:  330771

D339855

REVIEWER:	Donna S. Davis, Chemist

Reregistration Branch 1/Health Effects Division (7509P)

THROUGH:	Sheila Piper, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

		Toiya Goodlow, Chemist

Michael S. Metzger, Chief

Reregistration Branch 1/Health Effects Division (7509P)

Christina Swartz, Chief

Registration Action Branch 2/ Health Effects Division (7509P)

TO:		Barbara Madden

		Stacey Groce/Dan Rosenblatt

		Risk Integration, Minor Use, Emergency Response Branch

	            Registration Division (7505P)

Executive Summary

As required by the draft Standard Operating Procedure (SOP) for the implementation of the Threshold of Regulation (TOR) Policy, dietary risk assessments are required to demonstrate that the use poses minimal risk, a level defined in the SOP as risks less than 0.1% of both the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD).

The acute and chronic dietary risk assessments conducted support the TOR policy requirement that the use of thiabendazole as a seed treatment in/on dry pea poses minimal risk, as both acute and chronic risks were significantly below the TOR policy threshold of 0.1% of the acute and chronic population adjusted doses.

Thiabendazole is classified as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis”; therefore, quantification of human cancer risk is not required and a cancer dietary assessment was not performed.

I.	Introduction

In the Federal Register of October 27, 1999 (64 FR 57881), the EPA announced its Threshold of Regulation (TOR) Policy.  This policy established factors to consider and procedures to use when determining whether a use of a pesticide in a location and manner that has the possibility of resulting in residues in food is below the threshold of regulation.  The policy stated that a use may be below the threshold of regulation if, in addition to other criteria, the estimated potential risk of any theoretically possible residues in food is not of concern.

The Office of Pesticide Programs (OPP) has developed a draft Standard Operating Procedure (SOP) for the implementation of the Threshold of Regulation Policy.  That SOP directs HED to conduct dietary risk assessments to determine if the subject food use poses minimal risk.  The SOP defines minimal risk as acute and chronic dietary risks which are equal to, or less than 0.1% of both the acute and chronic population adjusted doses.

HED is currently reviewing a Section 3 request for the use thiabendazole as a seed treatment for dry pea.  HED believes that this use may be a candidate for a threshold of regulation approach.  In support of that regulatory approach, this memorandum documents the dietary exposure and risk assessments that were conducted to determine if the use of thiabendazole as a seed treatment for dry pea poses minimal risk as defined in the TOR SOP.

II.	Residue Information

Crop Field Trial DER for Dry Pea.  MRID 454282-01, D. Davis, 45428201.der

IR-4 submitted field trial data for thiabendazole on dry pea.  A total of five field trials were conducted in Zone 11 (2 trials in ID and 3 trials in WA) during the 1996 growing season.  Thiabendazole (30% FlC formulation) was formulated with water and seed dye and applied to dry pea seed at a seed treatment facility, at a nominal rate of 0.075 lb ai/100 lb seed.  Treated seed was planted within 10 days of seed treatment, and samples of dry pea were collected from the field trial sites at maturity, 83-90 days after planting.

Samples of dry pea were analyzed for residues of thiabendazole per se using an HPLC/FLD method.  The lower limit of the method validation (LLMV) was 0.05 ppm; the LOD was not reported, however sufficient sample chromatograms were provided to allow the reviewer to estimate the method limit of detection (LOD) at <0.02 ppm.  This method was adequately validated and determined appropriate for use as a data collection method based on acceptable concurrent recovery data.  Further, the residue data were supported by adequate storage stability data.

Duplicate samples were analyzed for residues of thiabendazole at each of the five field trial locations.  Residues of thiabendazole were less than the method LOD of 0.02 ppm in all ten field trial samples.

No data were provided on residues of benzimidazole, a regulated metabolite of thiabendazole; however, HED notes that in three diverse crops, wheat, soybean and sugar beets, residues of benzimidazole were consistently less than residues of the parent compound, thiabendazole.  Since the proposed use is for a seed treatment application, and since residues of parent compound were below the limit of detection, HED concludes that residues of benzimidazole are not likely to be detectable in dried peas grown from thiabendazole treated seed.

As directed by the TOR SOP, only residues of thiabendazole in/on dry pea were included in the analyses. Acute and chronic assessments were conducted that included residues of thiabendazole on dry pea at ½ the limit of detection (LOD), which is 0.01 ppm.

DEEM-FCID™ Program and Consumption Information

Thiabendazole TOR 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 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 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.

IV.	Toxicological Information

The thiabendazole toxicological doses and endpoints for dietary risk assessment purposes are summarized in the table below.

Table 1.  Summary of Thiabendazole Dietary Endpoints

Exposure Scenario	Point of Departure	Uncertainty/

FQPA Factor	RfD, PAD, Level of Concern	Study and Toxic Effects

Acute Dietary

(females 13 – 49 years)	NOAEL = 150 mg/kg/day	UFA = 10

UFH = 10	aRfD =

1.5 mg/kg/day

aPAD =

1.5 mg/kg/day	Developmental Study in the Rabbit

LOAEL = 600 mg/kg/day based on increase in total number of resorptions

Acute Dietary

(general population)	No effect attributable to a single dose seen in the database

Chronic Dietary	NOAEL =

10 mg/kg/day	UFA = 10

UFH = 10	cRfD =

0.1 mg/kg/day

cPAD =

0.1 mg/kg/day	2-Year Feed/chronic

Carcinogenicity in the Rat

LOAEL = 30 mg/kg/day based on decreased body weight gains and liver hypertrophy

Cancer	Classified as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis”

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.

V.	Results/Discussion

Acute Dietary Exposure and Risk Assessment

Assuming a theoretical potential residue of 0.01 ppm in/on dry pea with 100% crop treated resulted in an exposure value of “0.000000” for females 13 – 49 years of age, the subpopulation of concern for this risk assessment.    The estimated acute risk for females 13 – 49 years of age is significantly below the TOR maximum risk level of 0.1% of the aPAD.  The output from the acute dietary exposure and risk assessment is included as Attachment 1 of this review and the results are summarized in Table 2, below.

Chronic Dietary Exposure and Risk Assessment

Assuming a theoretical potential residue of 0.01 ppm in/on dry pea with 100% crop treated resulted in an exposure value of “0.000000” for the general population and for all subpopulations of concern.  The estimated chronic risk for the U.S. population and all subpopulations of concern is significantly below the TOR maximum risk level of 0.1% of the cPAD.  The output from the chronic dietary exposure and risk assessment is included as Attachment 2 of this review and the results are summarized in Table 2, below.

Cancer Dietary Exposure and Risk Assessment

Thiabendazole has been classified as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis”.  HED is currently regulating chronic dietary risk with a chronic RfD that reflects a dose level below dose levels at which thyroid hormone balance is impacted and consequently is also being protective of potential carcinogenic effects.  Therefore, a cancer dietary assessment was not performed.

Table 2.  Summary of Dietary (Food Only) Exposure and Risk for Thiabendazole

Population Subgroup	Acute Dietary

(95th 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	0.000000	<0.01

All Infants (< 1 year old)

0.000000	<0.01	N/A	N/A

Children 1-2 years old

0.000000	<0.01

Children 3-5 years old

0.000000	<0.01

Children 6-12 years old

0.000000	<0.01

Youth 13-19 years old

0.000000	<0.01

Adults 20-49 years old

0.000000	<0.01

Adults 50+ years old

0.000000	<0.01

Females 13-49 years old	0.000000	<0.01	0.000000	<0.01

VI.	Conclusions

The acute and chronic dietary risk assessments conducted support the TOR policy requirement that the use of thiabendazole as a seed treatment in/on dry pea poses minimal risk, as both acute and chronic risks were significantly below the TOR policy threshold of 0.1% of the acute and chronic population adjusted doses.

VII.	List of Attachments

Attachment 1.  Acute Dietary Assessment Dry Pea Only

Attachment 2.  Chronic Dietary Assessment Dry Pea Only

Attachment 1.  Acute Dietary Assessment – Dry Pea Only

U.S. Environmental Protection Agency                                 Ver. 2.02

DEEM-FCID Acute analysis for THIABENDAZOLE

Residue file name: C:\Documents and Settings\ddavis05\DEEM files\thiabend dry pea only.R98

Analysis Date 05-15-2007             Residue file dated: 05-15-2007/07:43:14/8

Reference dose: aRfD = 1.5 mg/kg bw/day  NOEL = 150 mg/kg bw/day

Comment: Cancer POD is 10 mg/kg/day

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

06032560 6C   Pea, dry                           0.010000   1.000  1.000  1/2 es

          Full comment: 1/2 estimated LOD; 100% CT

06032561 6C   Pea, dry-babyfood                  0.010000   1.000  1.000  1/2 es

          Full comment: 1/2 estimated LOD; 100% CT

U.S. Environmental Protection Agency                                  Ver. 2.02

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

Residue file: thiabend dry pea only.R98           Adjustment factor #2 NOT used.

Analysis Date: 05-15-2007/07:44:08    Residue file dated: 05-15-2007/07:43:14/8

NOEL (Acute) = 150.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Cancer POD is 10 mg/kg/day"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE

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

Females 13-50 yrs:

  0.000000   0.00 >1000000    0.000000    0.00 >1000000    0.000007   0.00 >1000000

Attachment 2.  Chronic Dietary Assessment Dry Pea Only

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for THIABENDAZOLE                      1994-98 data

Residue file: C:\Documents and Settings\ddavis05\DEEM files\thiabend dry pea only.R98

                                                           Adjust. #2 NOT used

Analysis Date 05-15-2007             Residue file dated: 05-15-2007/07:43:14/8

Reference dose (RfD) = 0.1 mg/kg bw/day

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

06032560 6C   Pea, dry                           0.010000   1.000      1.000   1/2 es

  Full comment: 1/2 estimated LOD; 100% CT

06032561 6C   Pea, dry-babyfood                  0.010000   1.000      1.000   1/2 es

  Full comment: 1/2 estimated LOD; 100% CT

U.S. Environmental Protection Agency                                 Ver. 2.00

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

Residue file name: C:\Documents and Settings\ddavis05\DEEM files\thiabend dry pea only.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 05-15-2007/07:45:11     Residue file dated: 05-15-2007/07:43:14/8

Reference dose (RfD, Chronic) = .1 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)                     0.000000                 0.0%

All infants (< 1 year)                      0.000000                 0.0%

Children 1-2 yrs                            0.000000                 0.0%

Children 3-5 yrs                            0.000000                 0.0%

Children 6-12 yrs                           0.000000                 0.0%

Youth 13-19 yrs                             0.000000                 0.0%

Adults 20-49 yrs                            0.000000                 0.0%

Adults 50+ yrs                              0.000000                 0.0%

Females 13-49 yrs                           0.000000                 0.0%

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

Thiabendazole	      Dietary Exposure and Risk Assessment	                D339855

PC Code:  060101

________________________________________________________________________ ______________

Page   PAGE  1  of   NUMPAGES  8

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[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Rules and Regulations]
[Pages 48300-48301]
[FR Doc No: 2021-18486]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-1147; Airspace Docket No. 20-ASO-30]
RIN 2120-AA66

Amendment of Area Navigation (RNAV) Route Q-29; Northeastern
United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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

SUMMARY: This action corrects a final rule published by the FAA in the
Federal Register on July 26, 2021, that amends area navigation (RNAV)
route Q-29 in the northeastern United States. This action is in support
of the Northeast Corridor Atlantic Coast Route Project (NEC ACR) for
improved efficiency of the National Airspace System (NAS) while
reducing the dependency on ground based navigational systems. This
action makes an administrative correction to the spelling of the final
point on the legal description of RNAV route Q-29.

DATES: Effective date 0901 UTC, October 7, 2021. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC, 20591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of FAA Order 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Sean Hook, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule for Docket No. FAA-2020-1147 in the
Federal Register (86 FR 39952; July 26, 2021), amending RNAV route Q-29
in the northeastern United States. The Q-route amendment supports the
strategy to transition the NAS from a ground-based navigation aid and
radar-based system to a satellite-based PBN system. The final point,
DUNOM, was incorrectly spelled in the legal description and this action
only corrects that error.
    United States area navigation routes are published in paragraph
2006 of FAA Order 7400.11E, dated July 21, 2020, and effective
September 15, 2020, which is incorporated by reference in 14 CFR 71.1.
The RNAV routes listed in this document will be published subsequently
in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020 and effective September 15, 2020.
FAA Order 7400.11E is publicly available as listed in the ADDRESSES
section of this document. FAA Order 7400.11E lists Class A, B, C, D,
and E airspace areas, air traffic service routes, and reporting points.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, the
description of RNAV route Q-29 as published in the Federal Register on
July 26, 2021 (86 FR 39952) is corrected as follows:

Paragraph 2006 United States Area Navigation Routes.

* * * * *

Q-29 HARES, LA to DUNOM, ME
----------------------------------------------------------------------------------------------------------------
HARES, LA                        WP                 (Lat. 33[deg]00'00.00'' N, long. 091[deg]44'00.00'' W)
BAKRE, MS                        WP                 (Lat. 33[deg]53'45.85'' N, long. 090[deg]58'04.75'' W)
MEMFS, TN                        WP                 (Lat. 35[deg]00'54.62'' N, long. 089[deg]58'58.87'' W)
OMDUE, TN                        WP                 (Lat. 36[deg]07'47.32'' N, long. 088[deg]58'11.49'' W)
SIDAE, KY                        WP                 (Lat. 37[deg]20'00.00'' N, long. 087[deg]50'00.00'' W)
CREEP, OH                        FIX                (Lat. 39[deg]55'15.28'' N, long. 084[deg]18'31.41'' W)
KLYNE, OH                        WP                 (Lat. 40[deg]41'54.46'' N, long. 083[deg]18'44.19'' W)
DUTSH, OH                        WP                 (Lat. 41[deg]08'26.35'' N, long. 082[deg]33'12.68'' W)
WWSHR, OH                        WP                 (Lat. 41[deg]20'34.09'' N, long. 082[deg]03'05.76'' W)
DORET, OH                        FIX                (Lat. 41[deg]48'05.90'' N, long. 080[deg]35' 04.64'' W)
Jamestown, NY (JHW)              VOR/DME            (Lat. 42[deg]11'18.99'' N, long. 079[deg]07'16.70'' W)
HANKK, NY                        FIX                (Lat. 42[deg]53'41.82'' N, long. 077[deg]09'15.21'' W)
GONZZ, NY                        WP                 (Lat. 43[deg]05'22.00'' N, long. 076[deg]41'12.00'' W)
KRAZZ, NY                        WP                 (Lat. 43[deg]25'00.00'' N, long. 074[deg]18'00.00'' W)
NIPPY, NY                        FIX                (Lat. 43[deg]41'23.08'' N, long. 073[deg]58'06.74'' W)
CABCI, VT                        WP                 (Lat. 44[deg]49'19.94'' N, long. 071[deg]42'55.14'' W)
EBONY, ME                        FIX                (Lat. 44[deg]54'08.68'' N, long. 067[deg]09'23.65'' W)
DUNOM, ME                        WP                 (Lat. 44[deg]54'09.29'' N, long. 066[deg]58'13.68'' W)

* * * * *

    Issued in Washington, DC, on August 23, 2021.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-18486 Filed 8-27-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]
[Page 42903-42904]
[DOCID:fr25au09-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Oncologic Drugs Advisory Committee.

    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 5, 2009, from
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The
Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel phone number
is<PHONE_NUMBER>.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512542. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough
to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot
line/phone line to learn about possible modifications before coming
to the meeting.
    Agenda: The committee will discuss the following topics:
    (1) Supplemental biologics license application (sBLA) 103949/
5153.0, PEGINTRON (peginterferon alfa-2b) injection, manufactured by
Schering Corp. The proposed indication (use) for this product is as
an adjuvant (additional) treatment for melanoma, a kind of skin
cancer. The primary treatment for melanoma that is metastatic (has
spread) to the lymph nodes is surgery to remove both the original
cancer and lymph nodes surrounding the cancer. PEGINTRON's proposed
use is as a treatment in addition to, or as an ``adjuvant,'' to
surgery.
    (2) New drug application (NDA) 022-465, proposed trade name
VOTRIENT (pazopanib) tablets, manufactured by GlaxoSmithKline. The
proposed indication (use) for this product is for the treatment of
patients with advanced renal cell carcinoma, a form of kidney
cancer.
    FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at http://www.fda.gov/
AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 21, 2009. Oral presentations from the public will be
scheduled between approximately 10:30 a.m. and 11 a.m., and between
approximately 3:30 p.m. and 4 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments
they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before September 11, 2009. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA
may conduct a lottery to determine the speakers for the scheduled
open public hearing session. The contact person will notify
interested persons regarding their request to speak by September 14,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to
electrical outlets.
    FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20379 Filed 8-24-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30054-30056]
[FR Doc No: 2021-11732]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0609]

Drug Supply Chain Security Act Implementation: Identification of
Suspect Product and Notification; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Drug
Supply Chain Security Act Implementation: Identification of Suspect
Product and Notification.'' The guidance addresses provisions in the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug
Supply Chain Security Act (DSCSA). The guidance is intended to aid
certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
specific scenarios that could significantly increase the risk of a
suspect product entering the pharmaceutical distribution supply chain.
The guidance also describes how trading partners should notify FDA of
illegitimate product and sets forth a process for terminating
notifications of illegitimate product in consultation with FDA. In
addition, this guidance describes when manufacturers should notify FDA
of a high risk that a product is illegitimate. This guidance responds
to comments from stakeholders in order to clarify certain points and
finalizes the remaining draft portion of the final guidance for
industry entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification,'' issued in
December 2016.

DATES: The announcement of the guidance is published in the Federal
Register on June 4, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2014-D-0609 for ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification; Guidance for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sarah Venti, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification.'' The guidance
addresses provisions in the FD&C Act, as amended by the DSCSA (Pub. L.
113-54). Section 202 of the DSCSA adds section 582(h)(2) to the FD&C
Act (21 U.S.C. 360eee-1(h)(2)), which requires FDA to issue guidance to
aid certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
terminating notifications. The guidance identifies specific scenarios
that could significantly increase the risk of a suspect product
entering the pharmaceutical distribution supply chain and provides
recommendations on how trading partners can identify such product and
determine whether the product is a suspect product as soon as
practicable.
    Beginning January 1, 2015, section 582 of the FD&C Act required
trading partners, upon determining that a product in their possession
or control is illegitimate, to notify: (1) FDA and (2) all immediate
trading partners that they have reason to believe may have received the
illegitimate product, not later than 24 hours after making the
determination. Manufacturers are additionally required under section
582(b)(4)(B)(ii)(II) of the FD&C Act to notify FDA and any immediate
trading partners that the manufacturer has reason to believe may
possess a product manufactured by (or purported to be manufactured by)
the manufacturer, not later than 24 hours after the manufacturer
determines or is notified by FDA or a trading partner that there is a
high risk that a product is illegitimate. The guidance also addresses
how trading partners should notify FDA using Form FDA 3911. In
addition, in accordance with section 582(h)(2) of the FD&C Act, the
guidance sets forth the process by which trading partners must
terminate the notifications using Form FDA 3911, in consultation with
FDA, regarding illegitimate product and, for a manufacturer, a product
with a high risk of illegitimacy, under section 582(b)(4)(B),
(c)(4)(B), (d)(4)(B), and (e)(4)(B) of the FD&C Act.
    This guidance finalizes the remaining draft portion of the guidance
for industry entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification,'' issued in
December 2016. In particular, this guidance finalizes section III.C,
which was issued for comment purposes in the December 2016 guidance.
This guidance will now be final in its entirety and replaces the
December 2016 guidance.
    In Federal Register of June 11, 2014 (79 FR 33564), FDA announced
the availability of a draft guidance entitled ``Drug Supply Chain
Security Act Implementation: Identification of Suspect Product and
Notification.'' In response to comments received on that guidance, in
the Federal Register of December 9, 2016 (81 FR 89112) FDA announced
the availability of a guidance

of the same title. This guidance was published as a final guidance for
industry with the exception of Section C entitled ``For Manufacturers:
High Risk of Illegitimacy Notifications''. This new section was
published as a draft guidance for industry and was added in response to
comments and questions received about the 2014 guidance. In addition,
based on comments on the 2014 guidance, Form FDA 3911, and the
instructions for completing the form, were slightly revised.
    FDA received comments on the 2016 guidance from various
stakeholders (e.g., pharmacy groups, wholesale distributor trade
groups). In response to these comments, FDA has made some changes for
clarity to the December 2016 version of the guidance. The changes
include: Clarifying what FDA believes an ``immediate trading partner''
to be; replacing ``suspicious'' with ``questionable'' throughout the
document; deleting the reference to ``pedigree'' in section III.A.1;
clarifying that trading partners should consider whether product has
been subject to a public alert or announcement of drug quality when
considering scenarios that could increase the chances that a suspect
product could enter the supply chain; in section III.B, clarifying that
FDA's recommendations apply only ``as applicable'' to the individual
trading partners; clarifying that trading partners only work with
authorized trading partners in section III.B; and stating that trading
partners should consult with manufacturers when conducting an
investigation of suspect product.
    In response to stakeholder comments, FDA has also made some changes
to the newly final section, III.C. These include: Clarifying that while
manufacturers need not notify FDA of suspect product, they must do so
if the circumstances surrounding the suspect product include at least
one of three types of high risk factors; clarifying that manufacturers
can learn of product with a high risk of illegitimacy either through
their own investigation of suspect product, or through information they
receive from a variety of other sources, including from within their
own company, from their trading partners, from the FDA, or from other
domestic and/or foreign regulatory authorities; clarifying that a
manufacturer must make a notification to FDA where it is investigating
the validity of the claim that a product has been stolen or diverted,
and the manufacturer has reason to believe that an immediate trading
partner has the potentially stolen or diverted product in its
possession; and clarifying that while not a requirement, FDA does
suggest that manufacturers inform trading partners of ``specific high
risk[s]''.
    Finally, while FDA received a few comments on section IV of this
guidance, which addresses notifications for illegitimate products and
products with a high risk of illegitimacy, along with termination of
those notifications, FDA did not incorporate the feedback from comments
on response times because we feel that a 10-day response time is a
reasonable amount of time for the Agency to review and evaluate such
requests for the termination of notification of illegitimate product.
Similarly, FDA did not add language on disclosure because the
information submitted to FDA using Form FDA 3911 is treated like all
other records obtained by FDA in regard to disclosure. FDA did make
some revisions for clarity however, which include adding a brief
discussion and footnote to FDA's guidance document Definitions of
Suspect Product and Illegitimate Product for Verification Obligations
Under the Drug Supply Chain Security Act. In addition, editorial
changes were made throughout the entire guidance for clarity and
references to section III.C being published for comment purposes only
were removed.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Drug Supply Chain Security Act
Implementation: Identification of Suspect Product and Notification.''
It does not establish any rights for any person and, with the exception
of section IV.B, is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
    As noted, section IV.B of this guidance, which sets forth the
process by which trading partners must terminate notifications of
illegitimate product and products with a high risk of illegitimacy in
consultation with FDA, has binding effect, where indicated by the use
of the words must, shall, or required. Such binding effect is
authorized by section 582(h)(2)(A) of the FD&C Act, wherein Congress
granted authorization to FDA to implement the process for terminating
notifications of illegitimate product in consultation with FDA through
guidance.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collection
of information in this guidance has been approved under OMB control
number 0910-0806.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11732 Filed 6-3-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 137 (Wednesday, July 19, 2017)]
[Notices]
[Pages 33144-33146]
[FR Doc No: 2017-15175]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-B-1730]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR). The LOMR will be used by
insurance agents and others to calculate appropriate flood insurance
premium rates for new buildings and the contents of those buildings.
For rating purposes, the currently effective community number is shown
in the table below and must be used for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: June 16, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Chief executive                            Online location
       State and county         Location and case      officer of          Community map      of letter of map       Effective date of        Community
                                       No.             community            repository            revision              modification             No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona: Greenlee.............  Unincorporated     The Honorable      Greenlee County,        http://www......  Sep. 14, 2017..............       040110
                                 Areas of           David Gomez,       Planning and Zoning    msc.fema.gov/
                                 Greenlee County    Chairman, Board    Department, 253 5th     lomc.
                                 (17-09-0131P).     of Supervisors,    Street, Clifton, AZ
                                                    Greenlee County,   85533.
                                                    P.O. Box 908,
                                                    Clifton, AZ
                                                    85533.
California:
    Riverside.................  City of Wildomar   The Honorable      City Hall, 23873        http://www......  Sep. 15, 2017..............       060221
                                 (17-09-0430P).     Timothy Walker,    Clinton Keith Road,    msc.fema.gov/
                                                    Mayor, City of     Suite 201, Wildomar,    lomc.
                                                    Wildomar, 23873    CA 92595.
                                                    Clinton Keith
                                                    Road, Suite 201,
                                                    Wildomar, CA
                                                    92595.
    Riverside.................  Unincorporated     The Honorable      Riverside County Flood  http://www......  Sep. 8, 2017...............       060245
                                 Areas of           John F.            Control and Water      msc.fema.gov/
                                 Riverside County   Tavaglione,        Conservation            lomc.
                                 (17-09-0232P).     Chairman, Board    District, 1995 Market
                                                    of Supervisors,    Street, Riverside, CA
                                                    Riverside          92502.
                                                    County, 4080
                                                    Lemon Street,
                                                    5th Floor,
                                                    Riverside, CA
                                                    92501.
Hawaii:
    Honolulu..................  City and County    The Honorable      Department of Planning  http://www......  Sep. 8, 2017...............       150001
                                 of Honolulu, (16-  Kirk Caldwell,     and Permitting, 650    msc.fema.gov/
                                 09-2530P).         Mayor, City of     South King Street,      lomc.
                                                    Honolulu, 530      Honolulu, HI 96813.
                                                    South King
                                                    Street, Room
                                                    300, Honolulu,
                                                    HI 96813.
    Maui......................  Maui County (17-   The Honorable      County of Maui          http://www......  Sep. 8, 2017...............       150003
                                 09-0740P).         Alan M. Arakawa,   Planning Department,   msc.fema.gov/
                                                    Mayor, Maui        2200 Main Street,       lomc.
                                                    County, 200        Suite 335, Wailuku,
                                                    South High         HI 96793.
                                                    Street, Kalana O
                                                    Maui Building,
                                                    9th Floor,
                                                    Wailuku, HI
                                                    96793.
Indiana: Marion...............  City of            The Honorable Joe  City Hall, 1200         http://www......  Sep.12, 2017...............       180159
                                 Indianapolis (17-  Hogsett, Mayor,    Madison Avenue, Suite  msc.fema.gov/
                                 05-1432P).         City of            100, Indianapolis, IN   lomc.
                                                    Indianapolis,      46225.
                                                    2501 City-County
                                                    Building, 200
                                                    East Washington
                                                    Street,
                                                    Indianapolis, IN
                                                    46204.
Kansas: Johnson...............  City of Overland   The Honorable      City Hall, 8500 Santa   http://www......  Sep. 5, 2017...............       200174
                                 Park (17-07-       Carl Gerlach,      Fe Drive, Overland     msc.fema.gov/
                                 0741P).            Mayor, City of     Park, KS 66212.         lomc.
                                                    Overland Park,
                                                    City Hall, 8500
                                                    Santa Fe Drive,
                                                    Overland Park,
                                                    KS 66212.
Michigan: Macomb..............  Charter Township   Mr. Robert J.      City Hall, 40700 Romeo  http://www......  Sep. 14, 2017..............       260121
                                 of Clinton (17-    Cannon,            Plank Road, Clinton    msc.fema.gov/
                                 05-2484P).         Supervisor,        Township, MI 48038.     lomc.
                                                    Charter Township
                                                    of Clinton,
                                                    40700 Romeo
                                                    Plank Road,
                                                    Clinton
                                                    Township, MI
                                                    48038.
Missouri: St. Louis...........  City of Maryland   The Honorable      Maryland Heights        http://www......  Sep. 15, 2017..............       290889
                                 Heights (17-07-    Michael Moeller,   Government Center,     msc.fema.gov/
                                 0909P).            Mayor, City of     11911 Dorsett Road,     lomc.
                                                    Maryland           Maryland Heights, MO
                                                    Heights, 11911     63043.
                                                    Dorsett Road,
                                                    Maryland
                                                    Heights, MO
                                                    63043.
South Carolina: Spartanburg...  Unincorporated     Ms. Katherine L.   Spartanburg County      http://www......  Sep. 19, 2017..............       450176
                                 Areas of           O'Neill, County    Administration         msc.fema.gov/
                                 Spartanburg        Administrator,     Building, 366 North     lomc.
                                 County (17-04-     Spartanburg        Church Street,
                                 2662P).            County,            Spartanburg, SC 29303.
                                                    Administration
                                                    Building, 366
                                                    North Church
                                                    Street,
                                                    Spartanburg, SC
                                                    29303.
Wisconsin:
    Kenosha...................  Village of         Mr. John P.        Village Hall, 9915      http://www......  Sep. 12, 2017..............       550613
                                 Pleasant Prairie   Steinbrink,        39th Avenue, Pleasant  msc.fema.gov/
                                 (17-05-1426P).     Village            Prairie, WI 53158.      lomc.
                                                    President,
                                                    Village of
                                                    Pleasant
                                                    Prairie, Village
                                                    Hall, 9915 39th
                                                    Avenue, Pleasant
                                                    Prairie, WI
                                                    53158.
    Waukesha..................  Village of Sussex  Mr. Jeremy Smith,  Village Hall,           http://www......  Aug. 25, 2017..............       550490
                                 (17-05-0249P).     Village            N64W23760 Main         msc.fema.gov/
                                                    Administrator,     Street, Sussex, WI      lomc.
                                                    Village of         53089.
                                                    Sussex,
                                                    N64W23760 Main
                                                    Street, Sussex,
                                                    WI 53089.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-15175 Filed 7-18-17; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Notices]
[Pages 73103-73104]
[FR Doc No: 2012-29565]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68338; File No. SR-ICC-2012-22]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Schedule 502 of the ICC Rules To Update the Contract Reference
Obligation ISIN Associated With One Single Name Contract

December 3, 2012.
    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 November 19, 2012, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared primarily by ICC. ICC filed the proposal pursuant to
Section 19(b)(3)(A)(iii) of the Act,\3\ and Rule 19b-4(f)(3) \4\
thereunder, so that the proposal was effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The purpose of the proposed rule change is to update the Contract
Reference Obligation International Securities Identification Number
(``Contract Reference Obligation ISIN'') in Schedule 502 of the ICE
Clear Credit Rules in order to be consistent with the industry standard
reference obligation for one single name contract that ICC currently
clears (Kimco Realty Corporation).

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

    In its filing with the Commission, ICC 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. ICC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of these statements.

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

    ICC is updating the Contract Reference Obligation ISIN for Kimco
Realty Corporation in order to remain consistent with the industry
standard reference obligation. Also, the Contract Reference Obligation
ISIN update does not require any changes to the ICC risk management
framework. The only change being submitted is the update to the
Contract Reference Obligation ISIN for Kimco Realty Corporation in
Schedule 502 of the ICC Rules.
    Section 17A(b)(3)(F) of the Act \5\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities transactions and,
to the extent applicable, derivative agreements, contracts, and
transactions. ICC believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to ICC, in particular, with Section
17A(b)(3)(F),\6\ because the update to the Contract Reference
Obligation ISIN for Kimco Realty Corporation will facilitate the prompt
and accurate settlement of securities transactions and contribute to
the safeguarding of securities and funds associated with swap
transactions which are in the custody or control of ICC or for which it
is responsible. ICC is updating the Contract Reference Obligation ISIN
for Kimco Realty Corporation in order to ensure that Clearing
Participants are informed of the Contract Reference Obligation ISIN
update.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1(b)(3)(F).
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

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

    ICC does not believe the proposed rule change would have any
impact, or impose any burden, on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. ICC will notify the Commission of any written
comments received by ICC.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A)(iii) \7\ of the Act and Rule 19b-4(f)(3) \8\
thereunder because it is concerned solely with the administration of
the self-regulatory organization. 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.\9\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(3).
    \9\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

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-ICC-2012-22 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-ICC-2012-22. 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 filings will also be available
for inspection and copying at the principal office of ICE Clear Credit
and on ICE Clear Credit's Web site at https://www.theice.com/publicdocs/regulatory_filings/ICEClearCredit_111912.pdf.
    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-ICC-2012-22
and should be submitted on or before December 28, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-29565 Filed 12-6-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 3, 2009 (Volume 74, Number 40)]
[Notices]
[Page 9255-9256]
[DOCID:fr03mr09-71]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1819-DR; Docket ID FEMA-2008-0018]

Arkansas; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arkansas (FEMA-1819-DR), dated February 6, 2009, and
related determinations.

DATES: Effective Date: January 30, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective January 30, 2009.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. E9-4505 Filed 3-2-09; 8:45 am]

BILLING CODE 9111-23-P