May 8, 2015

MEMORANDUM

SUBJECT:	Analysis of Possible Vocational Vehicle Standards Based on Alternative Idle Cycle Weightings

FROM:	Lauren Steele, Environmental Engineer, OTAQ/ASD

TO:	Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

Introduction

      This memorandum presents estimated emission reductions and fuel consumption savings based on alternate weightings of the proposed GEM idle cycle for vocational vehicles.  Depending on additional information that may become available during the comment period, it is possible that the agencies may change the weighting of the idle cycle in the composite GEM cycles for vocational vehicles from the proposed values to values that better reflect real world vocational vehicle operation. This memo explores the effects of such change on technology effectiveness and vehicle performance, as simulated through GEM.              In GEM the emissions and fuel consumed during the idle cycle are time-based (grams or gallons per hour), and the distance-based emissions and fuel consumed while moving (grams or gallons per ton-mile) are calculated separately. Because the combined weightings of the three distance-based cycles plus the idle cycle total 100 percent, any increase in the weighting of idle cycle emissions causes a proportional decrease in weighting of the emissions while moving.  This means that the degree of weighting of the idle cycle influences the relative importance of idle reduction technology compared with technologies that reduce emissions while driving. For example, an increase in idle cycle weighting would lead to a smaller relative importance of technologies that reduce engine emissions and rolling resistance.        Range of Idle Cycle Weightings              According to preliminary work by the National Renewable Energy Laboratory (NREL), logged activity of vehicles in the NREL database indicates the overall percent of idle time ranges between eight and 50 percent, with most vehicles logging idle time between 18 and 33 percent.  Figure 1 shows an example summary of some NREL idle operation data for vocational vehicles.

                                                Figure 1: Percent Idle Time per Day per Vehicle.  Source: NREL

      Using the GEM tool, the agencies have estimated the effectiveness of workday idle reduction technology (neutral idle and stop-start) across a wide range of idle cycle weightings. Figures 2 and 3 present the estimated effectiveness of neutral idle and stop-start, respectively, for idle cycle weightings up to 50 percent.  The proposal case weights all weight classes of Regional vehicles at 10 percent idle, Multi-purpose vehicles at 15 percent idle, and Urban vehicles at 20 percent idle, regardless of engine type.  For each curve in the graph, the percent reduction from the GEM baseline is calculated from a baseline that uses the same weighting of idle as for the idle reduction technology case.  For example, at 30 percent idle cycle weighting, a MHD Urban vehicle with neutral idle would have a GEM score 5.5 percent lower than a baseline vehicle with that same idle cycle weighting.                                                 Figure 2: Change in Effectiveness of Neutral Idle Workday Idle Reduction Technology with Cycle Weighting

                                        Figure 3: Change in Effectiveness of Stop-Start Workday Idle Reduction Technology with Cycle Weighting

      Figure 4 presents the relative contribution to GEM baseline values (no added technology and all vehicles idling at CITT emission rates) as the weighting of the idle cycle changes from zero to 50 percent. The emission rates in grams of CO2 per ton-mile decrease with increasing idle weighting due to the relatively lesser weighting of emissions over the ARB transient, 55 mph cruise and 65 mph cruise cycles. In the example of the HHD Urban vehicle (dark green bars on the graph), the contribution of the ARB Transient cycle is about 40 percent of the total mass of CO2 in g/ton-mi when the idle cycle is weighted zero (first cluster of bars). In the case of a 30 percent idle cycle weighting, the transient contribution from this same HHD Urban vehicle would be about 36 percent of the total mass of CO2 in g/ton-mi.

                                                 Figure 4: Change in Baseline Performance with Idle Cycle Weighting


[Federal Register Volume 85, Number 127 (Wednesday, July 1, 2020)]
[Rules and Regulations]
[Pages 39491-39494]
[FR Doc No: 2020-13048]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0046; FRL-10009-25]

Cyflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
cyflumetofen in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 1, 2020. Objections and
requests for hearings must be received on or before August 31, 2020 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0046, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
    Please note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0046 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
August 31, 2020. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential

pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0046, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 19, 2019 (84 FR 16430) (FRL-9991-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E8724) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be amended by establishing tolerances
for residues of the insecticide cyflumetofen, 2-methoxyethyl a-cyano-a-
[4-(1,1-dimethylethyl)phenyl]-b-oxo-2-
(trifluoromethyl)benzenepropanoate, including its metabolites and
degradates, to be determined by measuring only cyflumetofen, in or on
the agricultural commodities: Cucumber at 0.15 parts per million (ppm);
fruit, stone, group 12-12 at 2.0 ppm; plum, prune, dried at 0.41 ppm;
strawberry at 0.80 ppm; and vegetable, fruiting, group 8-10 at 2.0 ppm.
The petition also requested that upon approval of the above tolerances
that 40 CFR 180.677 be amended by revising or removing the existing
tolerances for residues of the insecticide cyflumetofen, in or on the
agricultural commodities strawberry at 0.60 ppm and tomato at 0.40 ppm.
That document referenced a summary of the petition prepared by BASF,
the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing some tolerances at different levels than requested and in
some cases is establishing tolerances for different commodities than
requested. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for cyflumetofen including exposure
resulting from the tolerances established by this action.
    On May 8, 2019, EPA published in the Federal Register a final rule
establishing a tolerance for residues of the insecticide cyflumetofen
in or on tea, dried. See 84 FR 20037 (FRL-9990-60). That document
contains a summary of the toxicological profile, assumptions for
dietary exposure assessment, cumulative risk, and the safety factor for
children, which have not changed. Further information about EPA's risk
assessment and determination of safety supporting the tolerances
established in the May 8, 2019 Federal Register action can be found at
http://www.regulations.gov in the document titled, ``Cyflumetofen.
Human Health Risk Assessment to Support New Uses on Imported Tea''
dated March 4, 2019. The document can be found in docket ID EPA-HQ-OPP-
2017-0532.
    The Agency conducted a revised risk assessment to incorporate
exposure to residues of cyflumetofen from use on the cucumber, the
stone fruit group 12-12, strawberries, and the fruiting vegetable group
8-10. EPA's aggregate exposure assessment incorporated this additional
dietary exposure, as well as exposure in drinking water, although
drinking water exposures are not impacted by the new uses. In addition,
the aggregate exposure assessment no longer includes residential
handler exposures; no post-application exposures were assessed due to a
lack of residential post-application exposures and lack of dermal
hazard.
    As indicated in the supporting documents, no acute dietary exposure
and risk analysis was performed for cyflumetofen since there were no
appropriate studies identified in the toxicology database that
demonstrated evidence of toxicity attributable to a single dose.
Chronic dietary (food and water) risks are below the Agency's level of
concern of 100% of the chronic population adjusted dose (cPAD); they
are 3% of the cPAD for children 1-2 years old, the group with the
highest exposure level. Because EPA has determined there are no
residential exposures, the chronic dietary risk is the same as the
overall aggregate risk for cyflumetofen.
    Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children from
aggregate exposure to cyflumetofen residues.
    More detailed information on the subject action to establish a
tolerance in or on cucumber, the stone fruit group 12-12, prunes,
strawberries, and the fruiting vegetable group 8-10 can be found in the
document titled, ``Cyflumetofen. Human Health Risk Assessment for the
Section 3 Registration Action for New Uses on Fruiting Vegetable (Crop
Group 8-10), Stone Fruits (Crop Group 12-12), and Greenhouse Uses on
Fruiting Vegetable, Cucumber, and Strawberry'', dated April 29, 2020,
by going to http://www.regulations.gov. The referenced document is
available in the docket established by this action, which is described
under ADDRESSES. Locate and click on the hyperlink for docket ID number
EPA-HQ-OPP-2019-0046.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available to enforce the Agency-
recommended tolerances for

cyflumetofen in plant commodities. The high-performance liquid
chromatography with tandem mass spectrometry (HPLC-MS/MS) method, BASF
D1003, has been adequately validated, has undergone a successful ILV
(independent laboratory validation), is considered adequately radio-
validated and has been reviewed by the Agency for appropriateness as an
enforcement method. Cyflumetofen has also been subjected to analysis by
the Food and Drug Administration (FDA) multi-residue method (MRM)
protocols. Cyflumetofen is not adequately recovered through any of the
FDA multi-residue protocols.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are Codex MRLs established for cyflumetofen residues in/on
strawberry (0.6 ppm) and tomato (0.3 ppm). The strawberry tolerance is
harmonized with Codex. The tolerance for tomato is not harmonized with
Codex; harmonization is not possible at this time since lowering the
newly established U.S. tolerance may result in over-tolerance residues
in the United States.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance for cucumber at 0.3 ppm rather
than the petitioned-for tolerance level of 0.15 ppm to fully account
for residue loss from the field trial samples during freezer storage
from the time of harvest to the time of analysis.
    EPA is establishing tolerances for the subgroups in the stone fruit
crop group 12-12 rather than the whole crop group based on the highest
maximum residue limit (MRL) calculated for each of the representative
crops: Cherry (1.5 ppm), peaches (0.4 ppm), and plums (0.3 ppm) to
harmonize with Canada's MRLs.
    A tolerance is not required for dried plums (prune) because this
commodity is covered under the plum subgroup 12-12C tolerance.
    For strawberry, the Agency is maintaining the existing tolerance to
remain harmonized with Codex. Although the Organization for Economic
Cooperation and Development (OECD) MRL calculator produces a tolerance
of 0.8 ppm for (greenhouse) strawberry, the currently established
tolerance level for strawberry (0.60 ppm) is adequate for foliar and
greenhouse uses. EPA is revising the strawberry tolerance to 0.6 ppm
based on OECD rounding classes.
    EPA is establishing tolerances for the tomato subgroup 8-10A at 0.7
ppm and pepper/eggplant subgroup 8-10B at 2 ppm rather than the full
crop group vegetable, fruiting, group 8-10 in order to harmonize with
the Canadian tolerances on tomato and pepper.

V. Conclusion

    Therefore, tolerances are established for residues of cyflumetofen,
(2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), in or on cherry
subgroup 12-12A at 1.5 ppm; cucumber at 0.3 ppm; peach subgroup 12-12B
at 0.4 ppm; pepper/eggplant subgroup 8-10B at 2 ppm; plum subgroup 12-
12C at 0.3 ppm; and tomato subgroup 8-10A at 0.7 ppm.
    Additionally, the existing tolerance on tomato is removed as
unnecessary due to the establishment of the above tolerances. Also, the
existing tolerance for strawberry is modified to 0.6 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies tolerances under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S.

Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 8, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.677amend the table in paragraph (a) by:
0
i. Adding alphabetically the commodities ``Cherry subgroup 12-12A'';
``Cucumber''; ``Peach subgroup 12-12B''; ``Pepper/eggplant subgroup 8-
10B''; ``Plum subgroup 12-12C''; and ``Tomato subgroup 8-10A'';
0
ii. Revise the tolerance entry for ``Strawberry''; and
0
iii. Remove the commodity ``Tomato'' from the table in paragraph (a).
    The additions and revisions read as follows:

Sec.  180.677   Cyflumetofen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Cherry subgroup 12-12A......................................         1.5

                                * * * * *
Cucumber....................................................         0.3

                                * * * * *
Peach subgroup 12-12B.......................................         0.4
Pepper/eggplant subgroup 8-10B..............................           2
Plum subgroup 12-12C........................................         0.3
Strawberry..................................................         0.6

                                * * * * *
Tomato subgroup 8-10A.......................................         0.7
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-13048 Filed 6-30-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Pages 64933-64935]
[FR Doc No: 2011-26982]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14285-000]

Alaska Power Company, Inc.; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On September 12, 2011, Alaska Power Company, Inc., 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
Moira Sound Hydroelectric Project (Moira Sound Project or project) to
be located on Dickman, Kugel, Aiken, Luelia, and Niblack Creeks; Lake
Luelia, Kugel and Aiken Lakes, and seven unnamed lakes near Hollis, on
Prince of Wales Island in the Prince of Wales--Hyder Census Area,
Alaska. The project as proposed would occupy 10,041 acres, 7,839 acres
of which are lands of the Tongass National Forest, managed by the U.S.
Forest Service. 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 11 developments, plus support
facilities for the project. All proposed facilities are new.

Lower Kugel Development

    (a) The Lower Kugel Development would consist of the following: (1)
A 300-foot-long, 65-foot-high concrete gravity dam, which would raise
the elevation of the existing Kugel Lake from 397 feet mean sea level
(msl) to 450 feet msl; (2) a 2,900-foot-long penstock consisting of a
900-foot-long, 5-foot-diameter buried high density polyethylene (HPDE)
section and a 2,000-foot-long, 4.5-foot-diameter buried ductile iron
section; (3) a 40-foot-long, 60-foot-wide powerhouse containing one
4.1-megawatt (MW) turbine/generator unit with an adjacent 40-foot-long,
40-foot-wide substation; (4) a 30-foot-long tailrace returning flows
from the powerhouse to Kugel Creek; (5) three access roads, totaling
1.6 miles in length; (6) a 0.2-mile-long, 69-kV transmission line from
the Lower Kugel Development substation to the project substation; and
(7) appurtenant facilities.

Middle Kugel Development

    (b) The Middle Kugel Development would consist of the following:
(1) A 300-foot-long, 40-foot-high concrete-faced rockfill dam, which
would raise the elevation of an existing unnamed lake (referred to as
Lake 930 in the project application) from 930 feet msl to 960 feet msl;
(2) a 6,700-foot-long, 4.5-foot-diameter buried ductile iron penstock;
(3) a 40-foot-long, 60-foot-wide powerhouse containing one 4.8-MW
turbine/generator unit with an adjacent 40-foot-long, 40-foot-wide
substation; (4) a 30-foot-long tailrace returning flows from the
powerhouse to Kugel Lake; (5) two access roads, totaling 2.9 miles in
length; (6) a 2.2-mile-long, 34.5-kV transmission line from the Middle
Kugel Development substation to the project substation; and (7)
appurtenant facilities.

Upper Kugel Development

    (c) The Upper Kugel Development would consist of the following: (1)
A 500-foot-long, 60-foot-high concrete-faced rockfill dam, which would
raise the elevation of an existing unnamed lake (referred to as Lake
1125 in the project application) from 1,125 feet msl to 1,175 feet msl;
(2) a 1,300-foot-long, 3-foot-diameter buried ductile iron penstock;
(3) a 30-foot-long, 50-foot-wide powerhouse containing one 0.9-MW
turbine/generator unit with an adjacent 30-foot-long, 40-foot-wide
substation; (4) a 30-foot-long tailrace returning flows from the
powerhouse to Lake 930; (5) a 0.8-mile-long access road; (6) a 0.5-
mile-long, 34.5-kV transmission line from the Upper Kugel Development
substation to the Aiken Development substation; and (7) appurtenant
facilities.

Aiken Development

    (d) The Aiken Development would consist of the following: (1) A
300-foot-long, 40-foot-high concrete-faced rockfill dam, which would
raise the elevation of Aiken Lake from approximately 1,119 feet msl to
1,150 feet msl; (2) a 3,500-foot-long penstock consisting of an 800-
foot-long, 5-foot-wide, 7-foot-high tunnel section and a 2,700-foot-
long, 2.5-foot-diameter buried HPDE section; (3) a 30-foot-long, 50-
foot-wide powerhouse containing one 0.4-MW turbine/generator unit with
an adjacent 30-foot-long, 50-foot-wide substation; (4) a 30-foot-long
tailrace returning flows from the powerhouse to Lake 930; (5) a 2-mile-
long access road; (6) a 1.3-mile-long, 34.5-kV transmission line from
the Aiken Development substation to the Middle Kugel Development
substation; and (7) appurtenant facilities.

Dickman Development

    (e) The Dickman Development would consist of the following: (1) A
300-foot-long, 60-foot-high concrete-faced rockfill dam, which would
raise the elevation of an existing unnamed lake (referred to as Lake
305 in the project application) from 305 feet msl to 350 feet msl; (2)
a 5,200-foot-long penstock consisting of a 3,300-foot-long, 4-foot-
diameter buried HPDE section and a 1,900-foot-long, 3.5-foot-diameter
buried ductile iron section; (3) a 40-foot-long, 60-foot-wide
powerhouse containing one 2.2-MW turbine/generator unit with an
adjacent 40-foot-long, 60-foot-wide substation; (4) a 30-foot-long
tailrace returning flows from the powerhouse to an unnamed creek
(referred to as Dickman Creek in the project application); (5) two
access roads, totaling 3.3 miles in length; (6) a 2.4-mile-long, 34.5-
kV transmission line from the Dickman Development substation to the
project substation; and (7) appurtenant facilities.

Lower Luelia Development

    (f) The Lower Luelia Development would consist of the following:
(1) A 150-foot-long, 45-foot-high concrete-faced rockfill dam, which
would raise the elevation of an existing unnamed lake (referred to as
Lake 592 in the project application) from 592 feet msl to 625 feet msl;
(2) a 1,500-foot-long penstock consisting of an 800-foot-long, 3.5-
foot-diameter buried HPDE section and a 700-foot-long, 3-foot-diameter
above-ground steel section; (3) a 40-foot-long, 60-foot-wide powerhouse
containing one 2.2-MW turbine/generator unit with an adjacent 40-foot-
long, 60-foot-wide substation; (4) a 30-foot-long tailrace returning
flows from the powerhouse to Luelia Creek; (5) two access roads,
totaling 3.6 miles in length; (6) a 2.3-mile-long, 69-kV transmission
line from the Lower Luelia Development substation to the project
substation; and (7) appurtenant facilities.

Middle Luelia Development

    (g) The Middle Luelia Development would consist of the following:
(1) A siphon intake in Lake Luelia; (2) a 1,700-foot-long penstock
consisting of a 500-foot-long, 4-foot-diameter buried HPDE section and
a 1,200-foot-long, 3.5-foot-diameter above-ground steel section; (3) a
40-foot-long, 60-foot-wide powerhouse containing one 2.3-MW turbine/
generator unit with an adjacent 40-foot-long, 60-foot-wide substation;
(4) a 30-foot-long tailrace returning flows from the powerhouse to Lake
592; (5) two access roads, totaling 1.2 miles in length; (6) a 1.1-
mile-long, 69-kV transmission line from the Middle Luelia Development
substation to the Lower Luelia Development substation; and (7)
appurtenant facilities.

Upper Luelia Development

    (h) The Upper Luelia Development would consist of the following:
(1) A 100-foot-long, 10-foot-high concrete gravity dam, which would
raise the elevation of an existing unnamed lake (referred to as Lake
1050 in the project application) from 1,050 feet msl to 1,055 feet msl;
(2) a 1,100-foot-long, 2.5-foot-diameter buried ductile iron penstock;
(3) a 30-foot-long, 50-foot-wide powerhouse containing one 0.4-MW
turbine/generator unit with an adjacent 30-foot-long, 50-foot-wide
substation; (4) a 20-foot-long tailrace returning flows from the
powerhouse to Lake Luelia; (5) two access roads, totaling 1.3 miles in
length; (6) a 1.5-mile-long, 69-kV transmission line from the Upper
Luelia Development substation to the Middle Luelia Development
substation; and (7) appurtenant facilities.

Lower Niblack Development

    (i) The Lower Niblack Development would consist of the following:
(1) A 250-foot-long, 30-foot-high concrete-faced rockfill dam, which
would raise the elevation of Myrtle Lake from 92 feet msl to 110 feet
msl; (2) a 900-foot-long,

3-foot-diameter buried HDPE penstock; (3) a 40-foot-long, 60-foot-wide
powerhouse containing one 0.4-MW turbine/generator unit with an
adjacent 40-foot-long, 60-foot-wide substation; (4) a 30-foot-long
tailrace returning flows from the powerhouse to Myrtle Creek; (5) two
access roads, totaling 1 mile in length; (6) a 0.7-mile-long, 34.5-kV
transmission line from the Lower Niblack Development substation to a
substation located at the Niblack Mine; and (7) appurtenant facilities.

Middle Niblack Development

    (j) The Middle Niblack Development would consist of the following:
(1) A 1,100-foot-long, 50-foot-high concrete-faced rockfill dam, which
would raise the elevation of an existing unnamed lake (referred to as
Lake 630 in the project application) from 630 feet msl to 670 feet msl;
(2) a 3,400-foot-long, 3-foot-diameter ductile iron penstock, installed
within an access tunnel; (3) a 40-foot-long, 60-foot-wide powerhouse
containing one 2.1-MW turbine/generator unit with an adjacent 40-foot-
long, 40-foot-wide substation; (4) a 20-foot-long tailrace returning
flows from the powerhouse to Myrtle Lake; (5) two access roads,
totaling 2.6 miles in length; (6) a 1.3-mile-long, 69-kV transmission
line from the Middle Niblack Development substation to the Lower
Niblack Development substation; and (7) appurtenant facilities.

Upper Niblack Development

    (k) The Upper Niblack Development would consist of the following:
(1) A 100-foot-long, 10-foot-high concrete gravity dam, which would
raise the elevation of an existing unnamed lake (referred to as Lake
1300 in the project application) from 1,300 feet msl to 1,305 feet msl;
(2) a 3,100-foot-long penstock, which would include a 900-foot-long,
1.5-foot-diameter HDPE section and a 2,200-foot-long, 1.5-foot-diameter
above-ground steel section; (3) a 30-foot-long, 50-foot-wide powerhouse
containing one 0.6-MW turbine/generator unit with an adjacent 30-foot-
long, 50-foot-wide substation; (4) a 20-foot-long tailrace returning
flows from the powerhouse to Lake Luelia; (5) a 1.3-mile-long access
road; (6) a 1.5-mile-long, 69-kV transmission line from the Upper
Niblack Development substation to the Upper Luelia Development
substation and the Middle Luelia Development substation; and (7)
appurtenant facilities.
    (l) The support facilities for the project would consist of the
following: (1) A marine access facility located on the shore of Dickman
Bay, which would include a barge landing, a boat ramp, and a boat/
seaplane dock; (2) a construction camp/staging area/maintenance
facility, which would include two residences for maintenance personnel,
and a garage/shop building; (3) a project substation located in the
construction camp/staging area/maintenance facility; (4) a 13.4-mile-
long, 69-kilovolt (kV) transmission line to transmit power from the
project substation to the Bokan Mountain mine; and (5) appurtenant
facilities.
    The total proposed generating capacity of the Moira Sound Project
would be 20.4 MW, with an estimated annual generation of 79.7 gigawatt-
hours.
    Applicant Contact: Mr. Robert S. Grimm, CEO/President, Alaska Power
Company, Inc., c/o Alaska Power & Telephone Company, P.O. Box 3222,
Port Townsend, WA 98368; phone:<PHONE_NUMBER>.
    FERC Contact: Jennifer Harper; phone:<PHONE_NUMBER>.
    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. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site 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_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
    Enter the docket number (P-14285-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: October 12, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-26982 Filed 10-18-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35653-35654]
[FR Doc No: 2015-15163]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2101]

Anoushirvan Sarraf: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Anoushirvan Sarraf from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Dr. Sarraf was
convicted of seven felonies under Federal law for conduct relating to
the regulation of a drug product. Dr. Sarraf was given notice of the
proposed permanent debarment and an opportunity to request a hearing
within the timeframe prescribed by regulation. Dr. Sarraf failed to
request a hearing. Dr. Sarraf's failure to request a hearing
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective June 22, 2015.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade (ELEM-4144) Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the regulation of any drug product under the FD&C Act.
    On July 23, 2014, the U.S. District Court for the Eastern District
of Virginia entered judgment against Dr. Sarraf after a jury found him
guilty of one count of conspiracy, in violation of 18 U.S.C. 371, three
counts of importation contrary to law, in violation of 18 U.S.C. 545
and 18 U.S.C. 2, two counts of receipt and delivery of misbranded
drugs, in violation of 21 U.S.C. 331(c), 333(a)(2), and 18 U.S.C. 2,
and one count of unlicensed wholesale distribution of prescription
drugs, in violation of 21 U.S.C. 331(t), 333(b)(1)(D), 353(e)(2)(A),
353(e)(3)(B), and 18 U.S.C. 2.
    FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein. The factual basis for these convictions
is as follows: Dr. Sarraf was a physician and owner of Aphrodite in
McLean, Virginia, in the Eastern District of Virginia. Dr. Sarraf
provided his medical license to Gallant Pharma International Inc.
(Gallant Pharma), for use by international co-conspirators, received
importations in his and Aphrodite's name on behalf of Gallant Pharma,
and purchased misbranded and non-FDA approved drugs and devices from
Gallant Pharma. In exchange for use of his medical license, mailing
name, and address, Dr. Sarraf received discounted pricing from Gallant
Pharma.
    Beginning in or around June 2009, and continuing until at least
August 2013, in the Eastern District of Virginia and elsewhere, Dr.
Sarraf knowingly and intentionally conspired and agreed to commit
offenses against the United States by: Fraudulently and knowingly
importing misbranded drugs; knowingly engaging in the wholesale
distribution of prescription drugs in Virginia without being licensed
to do so; receiving in interstate commerce, delivering and proffering
delivery for pay, misbranded drugs; defrauding the United States and
its Agencies by impeding, impairing, and defeating the lawful functions
of FDA to protect the health and safety of the public.
    Dr. Sarraf provided Gallant Pharma with his medical license to
enable Gallant Pharma to order non-FDA-approved chemotherapy and
cosmetic drugs from around the world, and allowed those drugs to be
shipped into the United States to Aphrodite. When the drugs arrived, he
would alert individuals at Gallant Pharma to retrieve the illegal
drugs. He additionally would take some of the misbranded and non-FDA-
approved drugs from the packages intended for Gallant Pharma for use on
his patients at Aphrodite.
    Between August 2009 and August 2012, Dr. Sarraf received and handed
off at least 40 shipments containing illegally imported drugs and
devices. Between August 2009 and August 2012, Dr. Sarraf purchased
approximately $250,000 in misbranded and non-FDA-approved drugs and
devices from Gallant Pharma.
    As a result of his convictions, on March 9, 2015, FDA sent Dr.
Sarraf a notice by certified mail proposing to permanently debar him
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
the finding, under section 306(a)(2)(B) of the FD&C Act, that Dr.
Sarraf was convicted of felonies under Federal law for conduct related
to the regulation of a drug product. FDA determined that Dr. Sarraf's
felony convictions were related to the regulation of drug products
because the conduct underlying his convictions undermined FDA's
regulatory oversight over drug products marketed in the United States,
by intentionally introducing into interstate commerce drug misbranded
products. The proposal also offered Dr. Sarraf an opportunity to
request a hearing, provided him 30 days from the date of receipt of the
letter in which to file the request, and advised him that failure to
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. The proposal was
received on March 12, 2015. Dr. Sarraf failed to respond within the
timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and has waived any contentions concerning his
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of
the FD&C Act, under authority delegated to the Director (Staff Manual
Guide 1410.35), finds that Anoushirvan Sarraf has been convicted of
seven felonies under Federal law for conduct relating to the regulation
of a drug product.
    As a result of the foregoing findings, Anoushirvan Sarraf is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or
382), or under section 351 of the Public Health Service Act (42 U.S.C.
262), effective (see DATES) (see section 201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B),
and 335a(c)(2)(A)(ii)). Any person with an approved or pending drug
product application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Anoushirvan Sarraf, in
any capacity during his debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Dr. Sarraf provides services in any capacity to a person with an
approved or pending drug product application during his period of
debarment he will be subject to civil money penalties (section
307(a)(7) of the Act (21 U.S.C. 335b(a)(7))). In addition, FDA will not
accept or review any abbreviated new drug applications submitted by or
with the assistance of Anoushirvan Sarraf during his period of
debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C.
335a(c)(1)(A))).
    Any application by Dr. Sarraf for special termination of debarment
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should
be identified with Docket No. FDA-2014-N-2101 and sent to the Division
of Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 16, 2015.
Douglass Stearn,
Director, Division of Compliance Policy, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2015-15163 Filed 6-19-15; 8:45 am]
BILLING CODE 4164-01-P