[Federal Register: April 6, 2010 (Volume 75, Number 65)]
[Notices]
[Page 17454-17456]
[DOCID:fr06ap10-91]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61805; File No. SR-BX-2010-022]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
the Price Improvement Period

March 31, 2010.
    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 March 25, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Chapter V, Section 18 (The Price
Improvement Period (``PIP'')) of the Rules of the Boston Options
Exchange Group, LLC (``BOX''). The text of the proposed rule change is
available from the principal office of the Exchange, at the
Commission's Public Reference Room and also on the Exchange's Internet
Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The PIP currently allows Initiating Participants \3\ to enter two-
sided orders for execution with the possibility of receiving a price
that improves upon the National Best Bid or Offer (``NBBO'') (``price
improvement''). The customer side of these orders (``PIP Order'') is
exposed \4\ to Options Participants to give them an opportunity to
compete for allocations in the PIP by entering orders (``Improvement
Orders'') at the proposed cross price or better. This provides an
opportunity for the PIP Order to receive price improvement. PIP Orders
are submitted to BOX with a matching guaranteed contra order (``Primary
Improvement Order''), equal to the full size of the PIP Order. The
Primary Improvement Order currently must represent a single price
(``Single-Priced Primary Improvement Order'') \5\ that is equal to or
better than that of the NBBO at the time of the commencement of the
PIP.
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    \3\ Options Participants, both OFPs and Market Makers, who
submit PIP Orders for price improvement.
    \4\ BOX commences a PIP by broadcasting a message to all Options
Participants that (1) states that a Primary Improvement Order has
been processed; (2) contains information concerning series, size,
PIP Start Price and side of the market, and; (3) states when the PIP
will conclude (``PIP Broadcast'').
    \5\ Presently, a Single-Priced Submission is the only manner in
which an Options Participant may start a PIP.
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    The purpose of this proposed rule change is to add an auto-match
functionality within the PIP for the Initiating Participant to submit a
Primary Improvement Order that will automatically match both the price
and size of all competing quotes and orders at any price level achieved
during the PIP auction or only up to a designated limit price (``Max
Improvement Primary Improvement Order''). Either the Single-Priced
Primary Improvement Order or the Max Improvement Primary Improvement
Order will designate the PIP auction start price (``PIP Start Price''),
which shall be equal to or better than the NBBO at the time of
commencement of the PIP. With a Max Improvement Primary Improvement
Order the Initiating Participant does not respond at all, but instead
must honor the prices set forth by the competing orders, including
booked unrelated orders, received from other Options Participants.
After the commencement of a PIP, the Initiating Participant would not
be able to cancel or modify the Max Improvement Primary Improvement
Order. In this case, the Initiating Participant would not have control
over the prices at which it receives an allocation at the conclusion of
the PIP auction.
    Under the proposal, at the conclusion of the PIP, the Max
Improvement Primary Improvement Order shall be allocated its full size
at each price level where there are competing quotes or orders, except
where restricted by any designated max improvement limit price, until a
price level is reached where the balance of the PIP Order can be fully
executed. Only at such price level will the Initiating Participant
retain priority for the greater of one contract or 40% of the remaining
size of the PIP Order.
    The following example illustrates how the proposed PIP auto-match
functionality will operate for the Max Improvement Primary Improvement
Order:

    At the commencement of the PIP the NBBO is 2.00 (bid)--2.10
(offer). The Initiating Participant submits to the PIP a customer
order to sell 155 contracts at $2.01 (``the PIP Order'') while
simultaneously submitting a guaranteed contra Max Improvement
Primary Improvement Order with a PIP Start Price of $2.01 (bid) and
a designated max improvement limit price of $2.04 (bid). During the
PIP auction the following competing orders were received from
Options Participants: PIP Participant A: $2.05 (bid) for 5 contracts
(a booked unrelated order); PIP Participant B: $2.03 (bid) for 15
contracts; PIP Participant C: $2.02 (bid) for 10 contracts; and PIP
Participant D: $2.01 (bid) for 155 contracts.
    The following allocations shall occur at the conclusion of the
PIP auction:

 Participant A is allocated 5 contracts at $2.05.
    [cir] Remaining size of PIP Order is 150.
    [cir] Note that Initiating Participant is not allocated any
quantity at this price level because it exceeds the Max Improvement
Primary Improvement Order designated limit price of $2.04.
 Initiating Participant and Participant B are each allocated
15 contracts at $2.03.

    [cir] Remaining size of PIP Order is 120.
 Initiating Participant and Participant C are each allocated
10 contracts at $2.02.
    [cir] Remaining size of PIP Order is 100.
 Initiating Participant is allocated 40 contracts at $2.01
(40% of the remaining quantity of 100 contracts) and Participant D
is allocated 60 contracts (balance of the remaining quantity of the
PIP Order after the Initiating Participant's allocation at this
price level).

    BOX's PIP allows for broad participation in its competitive auction
by all types of market participants (e.g. Public Customers, Broker
Dealers and Market Makers).\6\ All Options Participants are able to
receive the PIP Broadcasts and may respond by submitting competing
Improvement Orders. All PIP Orders entered into the PIP will continue
to be broadly exposed in the auction before the Initiating Participant
can execute against the PIP Order via the Max Improvement Primary
Improvement Order.
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    \6\ The Exchange notes that no changes to the priority of Public
Customer Orders within the PIP auction are being proposed.
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    BOX notes that when the Initiating Participant selects the Max
Improvement Primary Improvement Order prior to the start of the
auction, the available liquidity at improved prices would be
automatically doubled and competitive final pricing would be out of the
Initiating Participant's control. The Exchange believes that the
proposal, if approved, will increase competition in the PIP auction,
will provide more options contracts with price improvement and incent
Options Participants to initiate more such Max Improvement PIP
auctions. Increases in the number of PIP auctions initiated by BOX
Options Participants will directly correlate with an increase in the
number of customer orders that are provided with the opportunity to
receive price improvement over the NBBO.
    The Exchange also notes that a similar auto-match function is
currently in place on at least one other options exchange.\7\
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    \7\ See CBOE Rule 6.74A Automated Improvement Mechanism
(``AIM''). See also Securities Exchange Act Release No. 53222
(February 3, 2006), 71 FR 7089 (February 10, 2006) (SR-CBOE-2005-60)
(Order Granting Approval of Proposed Rule Change and Amendment No. 1
Thereto and Notice of Filing and Order Granting Accelerated Approval
to Amendment No. 2 to the Proposed Rule Change Relating to an
Automated Improvement Mechanism).
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    The Exchange represents that BOX shall provide the Commission with
the following data: The percentage of all BOX trades effected through
the PIP in which the Initiating Participant has submitted a Max
Improvement Primary Improvement Order with a limit price and the
percentage without a limit price, and the average amount of price
improvement provided to the PIP Order when the Initiating Participant
has submitted a Max Improvement Primary Improvement Order with a limit
price and the average without a limit price, versus the average amount
of price improvement provided to the PIP Order when the Initiating
Participant has chosen a Single-Priced Primary Improvement Order.
    After effectiveness of the proposal, and at least one week prior to
implementation of the rule change, BOXR will issue a regulatory
circular to Options Participants. The regulatory circular will inform
Options Participants of the implementation date of the Max Improvement
function. This will give Options Participants an opportunity to make
any necessary modifications to coincide with the implementation date.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\8\ in general, and Section
6(b)(5) of the Act,\9\ in particular, in that it is designed to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism for a free and open market and a national market
system and, in general, to protect investors and the public interest.
In particular, the Exchange believes that the proposal, if approved,
will result in double the liquidity available at improved prices with
competitive final pricing out of the Initiating Participant's control,
thus increasing competition in the PIP auction and providing more
options contracts with price improvement. As a result of the increased
opportunity for price improvement, the Exchange believes that Options
Participants will be incented to initiate more such Max Improvement PIP
auctions. Increases in the number of PIP auctions initiated by BOX
Options Participants will directly correlate with an increase in the
number of customer orders that are provided with the opportunity to
receive price improvement over the NBBO.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \12\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) \13\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange requests
that the Commission waive the 30-day operative delay because the
changes to the PIP auction will allow immediate increases in the
liquidity available at improved prices. The Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest and designates the proposal operative
upon filing.\14\
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2010-022 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-BX-2010-022. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission,\15\ all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-BX-2010-022 and should be submitted on or before April
27, 2010.
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    \15\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov/rules/sro.shtml.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-7693 Filed 4-5-10; 8:45 am]
BILLING CODE 8011-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

	Date:	26 September 2012

	SUBJECT:	Clothianidin  -  Proposed Label Amendments: Reduction in PHI for Crop Subgroup 8-10B (Peppers and Eggplant) and Change in Tolerance.

PC Code:  044309
DP Barcode:  D399953
Decision No.: 459388
Registration Nos.:  59639-150, 59639-152
Petition Nos.:  2F8008
Regulatory Action:  Amended Section 3
Risk Assessment Type:  N/A
Case No.:  7620
TXR No.:  N/A
CAS No.:  210880-92-5
MRID No.:  48708203, 48708204
40 CFR:180.586

	FROM:	Michael A. Doherty, Ph.D., Chemist
		Risk Assessment Branch II
		Health Effects Division (7509P)

	THROUGH:	Dennis McNeilly, Chemist
		Risk Assessment Branch II
		Health Effects Division (7509P)

	TO:	Marianne Lewis/Venus Eagle (RM 01)
		Insecticide-Rodenticide Branch
		Registration Division (7505P)

Introduction

Valent U.S.A. Corporation has petitioned the Agency to reduce the pre-harvest interval (PHI) from 7 days to 1 day following application of clothianidin products V-10170 2.013 SC or Arena 50 WDG to the fruiting vegetable crop subgroup 8-10B (pepper and eggplant).  Concomitant with that registration amendment, the registrant has requested changes in the tolerance for residues in/on fruiting vegetables (which currently is 0.2 ppm) as follows:
      8-10 Fruiting Vegetable Group except 8-10B Pepper/Eggplant subgroup	0.2 ppm
      8-10B Pepper Eggplant subgroup	0.7 ppm

Valent U.S.A. Corporation has submitted data depicting residues of clothianidin in/on bell and non-bell peppers reflecting a 1-day PHI.

Conclusion

The submitted data are adequate to support the reduction in the PHI and to revise the tolerances for the fruiting vegetable crop group.  The Health Effects Division recommends the following revision to 40 CFR 180.586:
   1. Delete the existing tolerance entry for Vegetable, fruiting, group 8 at 0.20 ppm.
   2. Establish a tolerance entry for Vegetable, fruiting, tomato subgroup 8-10A at 0.20 ppm
   3. Establish a tolerance entry for Vegetable, fruiting, pepper/eggplant subgroup 8-10B at 0.80 ppm.

Note that the recommended tolerance (0.80 ppm) for the pepper/eggplant crop subgroup is different than the requested tolerance (0.7 ppm).  HED used the OECD MRL Harmonization procedures to obtain the recommended tolerance level, which may account for the different values.  Also note that the commodity listing in the recommended tolerance expression is different than that petitioned for by the registrant.  The revised listing should be for Subgroup 8-10A, not 8-10 except the pepper/eggplant subgroup.

Detailed Considerations

Field Trial Data

Valent U.S.A Corporation submitted field trials depicting residues of clothianidin in/on bell peppers (six trials, MRID 48708204) and non-bell pepper (three trials, MRID 48708203).  For all trials, clothianidin (as V-10170 2.13 SC; EPA Reg. No. 59639-150) was applied, foliarly, two times, at a nominal application rate of 45.4 g a.i./A/application (0.1 lb a.i./A/application) and a retreatment interval of 7 days.  Peppers were harvested one day after the second application.  Residues of clothianidin were determined using Method RM-39C-1, which uses aqueous extraction, sorbent cleanup, and LC/MS-MS separation and detection.  Adequate performance has been demonstrated for this method and the studies are supported by adequate storage stability data.  The clothianidin residue data from the studies are summarized in the table below.  The number of field trials are in keeping with the guideline recommendations; however, the locations of the field trials are not as recommended by OCSPP Guideline 860.1500.  Nevertheless, they are considered to be adequate for purposes of this petition.

Summary of Residue Data for Clothianidin in/on Bell and Non-Bell Peppers Following a 1-Day PHI.
Pepper Type
Variety
Trial Location
Application Rates, g a.i./A
Clothianidin Residues, ppm
Average Residue +- Std. Dev., ppm
Bell
Hunter
Tift, GA
44.54 + 45.16
0.085, 0.123
0.104 +- 0.027

Heritage
Barnwell, SC
45.42 + 45.30
0.068, 0.049
0.059 +- 0.013

Green Bell
Seminole, FL
45.05 + 44.75
0.094, 0.083
0.089 +- 0.008

Revolution
Martin County, FL
46.34 + 46.49
0.048, 0.034
0.041 +- 0.010

McCabi
Yuma, AZ
46.38 + 45.89
0.122, 0.127
0.125 +- 0.004

Cal Wonder
Tulare County, CA
45.21 + 46.30
0.198, 0.225
0.212 +- 0.019
Non-Bell
Mesilla
Seminole, FL
44.4 + 45.2
0.312, 0.282, 0.311
0.302 +- 0.017

Dulce
Yuma, AZ
46.9 + 47.3
0.069, 0.082, 0.114
0.088 +- 0.023

Conch
Tift, GA
45.4 + 45.1
0.019, 0.015, 0.021
0.018 +- 0.003

Tolerance Determination

The tolerance recommended by HED is 0.80 ppm based on the non-bell-pepper residue data, and was derived using the OECD Calculation Procedures.  Data for bell and non-bell peppers were assessed separately (see below).  The recommended tolerances are 0.4 ppm based on bell peppers and 0.8 ppm based on non-bell peppers.  HED is recommending the higher value for all of Crop Subgroup 8-10B (Peppers and Eggplant).

Summary of Tolerance Derivation Calculations Using the OECD Calculation Procedures.
Compound
                                 Clothianidin
                                 Clothianidin
Crop
                               Non-Bell Peppers
                                 Bell Peppers
Region / Country
                                      USA
                                      USA
GAP

Total number of data (n)
                                       3
                                       6

Percentage of censored data
                                      0%
                                      0%
Number of non-censored data
                                       3
                                       6

Lowest residue
                                     0.018
                                     0.041
Highest residue
                                     0.302
                                     0.212
Median residue
                                     0.088
                                     0.097

Mean
                                     0.136
                                     0.105
Standard deviation (SD)
                                     0.148
                                     0.061

Correction factor for censoring (CF)
                                     1.000
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.302
                                     0.212
- Mean + 4 SD
                                     0.728
                                     0.347
- CF x 3 Mean
                                     0.408
                                     0.315
Unrounded MRL
                                     0.728
                                     0.347

Rounded MRL
                                      0.8
                                      0.4

High uncertainty of MRL estimate due to small dataset.
High uncertainty of MRL estimate due to small dataset.

Residues (mg/kg)
Residues (mg/kg)

                                     0.018

                                     0.104

                                     0.302

                                     0.059

                                     0.088

                                     0.089

                                     0.041

                                     0.125

                                     0.212


Publicly Releasable Summary of the Petition for Amending Tolerances

For the Fungicide Pyrimethanil In or On

Crop Group 11: Pome Fruit, Apple Wet Pomace, Milk, and Kidney of Cattle,
Goat, Horse and Sheep

EPA Registration Division contact: Mary L. Waller:<PHONE_NUMBER>

I. Pace International LLC

PP

EPA has received a pesticide petition (PP #) from Pace International
LLC, 5661 Branch Road, Wapato, WA 98951, proposing, pursuant to section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), to amend 40 CFR part 180.518 by increasing tolerances for
residues of the fungicide pyrimethanil
4,6-dimethyl-N-phenyl-2-pyrimidinamine in or on the raw agricultural
commodities for the pome fruit crop group, namely apples, crabapple,
loquat, mayhaw, pear, including oriental pear, and quince to 14 parts
per million (ppm), and pome fruit wet pomace to 56 ppm.

The petitioner, Pace International LLC, proposes to amend 40 CFR 180.518
to increase the tolerances for the combined residues of the fungicide 4,
6-dimethyl-N-phenyl-2-pyrimidinamine, expressed as pyrimethanil, and its
metabolite 4-[4,6-(dimethyl-2-pyrimidinyl) amino]phenol in or on kidney
of cattle, goat, horse, and sheep to 0.6 ppm and to increase the
tolerances for the combined residues of the fungicide 4,
6-dimethyl-N-phenyl-2-pyrimidinamine, expressed as pyrimethanil, and its
metabolite 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol in milk to 0.06
ppm.

EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
 Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The metabolic profile of pyrimethanil has been
investigated following application to five different crops (apple,
carrots, grapes, lettuce and tomatoes) and is well understood.  In
plants, pyrimethanil is the only significant residue ranging from
essentially all of the Total Radioactive Residues (TRR) in carrots and
tomatoes to 44% in lettuce. Limited metabolism of pyrimethanil occurs
with minor amounts (less than 10%) of the phenyl and pyrimidyl
hydroxylated metabolites (AE C614276, AE C614277, AE C614278 and AE
C621312) being released after acid hydrolysis. Analysis of the foliage
from apples and carrots confirmed that the metabolism of pyrimethanil in
plants proceeded primarily via hydroxylation of the aromatic ring
structures as well as the methyl groups.

	2. Analytical method.  The plant metabolism studies indicated that
analysis for the parent compound, pyrimethanil was sufficient to enable
the assessment of the relevant residues in crop commodities.
Pyrimethanil was extracted from apples by homogenization with acetone,
the extract acidified and washed with hexane and basified to enable
solvent partition  (ethyl acetate and hexane).  Final clean-up was by
silica SPE, with determination by gas chromatography with mass selective
detection.  The validated sensitivity of the method is 0.05 ppm for
pyrimethanil, which allows for the detection and measurement of residues
in or on pome fruits at or above the proposed tolerance level.

	3. Magnitude of residues. Magnitude of residue trials were conducted
for pyrimethanil applied postharvest to apples and pears by thermofog
application. Four trials were conducted, one in the U.S. in the state of
Washington, and three in the European Union (E.U.).

Pyrimethanil was applied by thermofog application at rates ranging from
5.2 grams AI/metric ton to 12 grams AI/m ton to pears and three apple
varieties, including gold and red delicious, and Jonagold.  Fruit were
treated directly from the field in storage rooms, without any prior
rinsing following commercial practice.  After treatment, the test
chamber remained closed more than 90 minutes before opened for fruit
residue sampling.  After dissipation of the fog, fruit samples were
taken for residue analysis. In one trial, residues were sampled from
both the top and bottom of the pallox container to assess the
homogeneity of the fog distribution within the storage container.  A
total of thirty residue samples were analyzed for the thermofog
application.  The mean residue was 2.6 ppm pyrimethanil (standard
deviation – 2.4), with a residue range of 0.25 – 8.68 ppm.

B. Toxicological Profile

	1. Acute toxicity.  Pyrimethanil is of low acute toxicity placing the
active ingredient in Toxicity Category II, III and IV.  Pyrimethanil is
non-irritating to the eyes and skin and is not a skin sensitizer.

	2. Genotoxicity. Pyrimethanil is not mutagenic or genotoxic in any
assay in either the presence or absence of metabolic activation.

	3. Reproductive and developmental toxicity. Pyrimethanil is not a
developmental or reproductive toxicant.

a.  Teratology - Rat

Thirty Sprague Dawley rats/group received doses of 0, 7, 85, 1,000 mg/kg
of pyrimethanil by gavage from gestation days (GD) 6-15.  At the highest
dose tested, reduced maternal body weight gain was observed during
GD6-15, along with a slight but statistically significant decrease in
food consumption, hair loss, hunched posture, slight emaciation, and
slightly reduced mean fetal body weight.  The maternal and developmental
NOEL was 85 mg/kg.

b.  Teratology - Rabbit

Groups of at least 18 time-mated New Zealand White rabbits received oral
gavage doses of 0, 7, 45 or 300 mg/kg/d pyrimethanil over gestation days
(GD) 7-19.  At the highest dose tested, there was a decrease in body
weight gain, production of feces and food consumption.  Three females
were euthanized due to severe emaciation.  The highest dose, 300
mg/kg/day exceeded the maternal maximum tolerated dose (MTD).  The
maternal NOAEL was 45 mg/kg/d due to reduced fecal production in 1/3 of
the animals. The high dose resulted in reduced mean fetal body weight,
increased incidence of runts, delayed skeletal ossification and
incidence of fetuses with 13 thoracic vertebrae and ribs. The maternal
NOEL was 7 mg/kg/day.  The developmental NOEL was 45 mg/kg/d.

c.  Two-Generation Reproduction - Rat

Three groups of 30 Sprague-Dawley rats per sex received dietary exposure
to pyrimethanil at levels of 0, 1.7, 20.9 or 266.7 mg/kg/d.  In the
parental generation at the highest dose tested there was a statistically
significant decrease in mean body weight gain in both sexes.  Mean pup
weights, observed on PND1 through weaning, were reduced, though were
within the range of historical controls.  In the F1 generation at the
highest dose tested, mean body weights and mean food consumption were
reduced.  Though the mean score for the combined sexes was the same as
the controls, a marginally different air-righting reflex at PND11
associated with reduced body weight was seen in high dose male pups.
The NOEL for maternal and developmental toxicity was 20.9 mg/kg/d.  The
reproductive NOEL was 266.7 mg/kg/d.

	4. Subchronic toxicity.

28-Day Dietary – Rat

Five Sprague-Dawley rats/sex/group received dietary exposure to
pyrimethanil for 28 days at 0, 844, 1,161, 1,500 and 2,710 mg/kg/day.
All doses exceeded the maximum tolerated dose.  Severe emaciation was
observed at all dose levels.  Body weight gains and food consumption
were reduced.  Liver and thyroid histopathology were observed, along
with reduced hemoglobin, MCV and MCH.  Kidney, adrenal and liver weights
were altered.  No NOEL or NOAEL was achieved.

90 Day Dietary – Rat

Ten Sprague-Dawley rats/sex/group received pyrimethanil in the diet at
dose levels of 0, 5.4-6.8, 54.5-66.7, 545-667 mg/kg/d (males and
females, respectively).  High dose animals had reduced body weight gain
and food consumption, increased urinary protein in males, colored urine
(not blood or bilirubin) and minimal hepatocellular hypertrophy.  The
NOAEL in males was 54.5-66.7 (males and females, respectively) due to
colored urine and a low incidence of minimal centrilobular
hepatocellular hypertrophy.  The NOEL was 5.4 mg/kg/d (males) -6.8
mg/kg/d  (females).

28-Day Dietary-Mouse

Five CD-1 mice/sex/group received dietary doses of 0, 167-236, 567-667,
1960-2357 mg/kg/d, males and females respectively, for 28 days (all the
mice in one additional high dose group, 30,000 ppm, died within the
first week of the study).  At  1960-2357 mg/kg/day, animals experienced:
 body weight loss (females), decreased body weight gain during the 1st
two weeks (males), a statistically significant decrease in cholesterol,
statistically significant decreases in relative liver weights (females),
pigmentation of thyroid follicles, urolithiasis, moderate urothelial
hyperplasia in urinary bladder, and slight kidney tubular degeneration
(females).  The NOEL was 167-236 mg/kg/d.

90-Day Dietary-Mouse

Twenty CD-1 mice/sex/group received pyrimethanil diet exposure at dose
levels of 0, 12-18, 139-203, 1,864-2,545 mg/kg/d males-females for 90
days.  At the high dose, animals had decreased body weight and increased
food consumption, cholesterol and total bilirubin.  High dose females
had increased relative liver weights.  Histopathology in the high dose
animals was found in the kidneys, liver, thyroid, and urinary bladder.
High dose males had slight urinary tract tubular dilation and slight to
moderate hyperplasia of bladder epithelium.  The NOEL was determined to
be 12 mg/kg/d (males) -18 mg/kg/d (females).  Based on mild hepatic
glycogen depletion, the NOAEL was 139-203 mg/kg/d (males and females,
respectively).

90-Day Dietary-Dog

Four beagle dogs/sex/group received pyrimethanil by gavage for 90 days
at doses of 0, 6, 80, 1,000 mg/kg/d.  The high dose was lowered to 800
mg/kg/d on day 7 due to frequent and consistent vomiting.  Decreased
body weight, food and water consumption were observed.  Males had a
significant reduction in phosphate, while females experienced a slight
reduction in sodium, anion gap and total protein.  At 80 mg/kg/day,
infrequent vomiting after dosing and decreased water consumption were
observed.  After 4 weeks of dosing at 80 mg/kg/day, males had
significantly reduced phosphate.  The NOAEL was 80 mg/kg/day.  The NOEL
was 6 mg/kg/day.

f.   Dermal Toxicity Evaluation

No dermal studies have been conducted for pyrimethanil.

	5. Chronic toxicity

a.  Chronic Toxicity - Dog

Four beagle dogs/sex/group received pyrimethanil by gavage at levels of
0, 2, 30, or 250 mg/kg/day for twelve months.  The high dose was reduced
from 400 to 250 mg/kg/day on day 8 of treatment due to excessive
vomiting during the first week of treatment. At the high dose, there was
a decrease in mean body weight gain and mean consumption of food and
water.  The NOEL for the study was 30 mg/kg/day, with the high dose of
250 mg/kg/day being the NOAEL.

b.  Combined Chronic Toxicity / Oncogenicity - Rat

Seventy Sprague-Dawley rats/sex/group received pyrimethanil by diet at
levels of 0, 1.3-1.8, 17-22, 221-291 mg/kg/day (males and females,
respectively) for two years.  At the highest dose tested, body weight
gain and food consumption were decreased.  Absolute liver weights were
increased.  Histopathology revealed centrilobular hepatocyte
hypertrophy, increased incidence of eosinophilic foci (males), thyroid
follicular hyperplasia, hypertrophy and colloid depletion, and the
presence of a brown pigment, identified as lipofuscin in thyroid
follicular cell epithelium.  There was a statistically significant,
dose-dependent increase in the incidence of benign thyroid follicular
cell adenomas.  There was no increased incidence in any malignant tumor
or increase in tumor multiplicity as a result of daily dietary ingestion
of pyrimethanil at any dose level.  The results of special studies,
discussed below, demonstrate that the benign thyroid tumors are likely a
secondary result of a disruption of thyroid-pituitary homeostasis, a
well-known, threshold-mediated mechanism.  The NOEL was 17 mg/kg/d
(males) and 22 mg/kg/day (females).

c.  Oncogenicity - Mouse

Fifty-one CD-1 mice/sex/group received pyrimethanil by diet at 0, 16,
160 and 1,600 ppm (corresponding to 0, 2-2.5, 20-24.9, 210.9-253.8
mg/kg/day in males and females, respectively).  There was an increase in
the number of high dose male deaths caused by urogenital tract lesions.
Urinary bladder histopathology on those dying during the course of the
study indicates an increase in the incidence of male urinary bladder
distension, cystitis, urothelial hyperplasia and inflammation of the
penis.  These findings are consistent with the findings of both the 28-
and 90-day studies indicating that high dose administration of
pyrimethanil resulted in urolith formation leading to irritation,
distension and hyperplasia of the urinary bladder and urinary tract.
Chronic dietary treatment with pyrimethanil produced no increased
incidence of tumor-bearing mice nor of any specific tumor type
suggestive of a carcinogenic effect. The NOEL for both sexes was 20-24.9
mg/kg/d (males and females, respectively).

d.  Special Studies

Since rodent thyroid tumors are fairly common, and since the EPA has
established that five lines of evidence are required to prove the
thyroid-pituitary disruption mode of action for rodent thyroid tumors,
special studies were undertaken

Thyroid mechanistic study (14-Day)

Sprague Dawley rats received 378.5 mg/kg/d of pyrimethanil for 14 days
to study the effects of pyrimethanil on the thyroid and liver microsomal
enzymes.  An increase in the levels of UDPGT and a corresponding
statistically significant increase in liver weight were observed.
Thyroid hormones T4 and T3 were decreased, while TSH levels were
significantly increased.  All effects were shown to be reversible.

Dietary Thyroid Function Test Using Perchlorate Discharge (7-Day)

Sprague Dawley rats received 509 mg/kg/d pyrimethanil or 177 mg/kg/d
propylthiouracil, or 109 mg/kg/d phenobarbital in order to study the
function of the thyroid gland.  The animals fed pyrimethanil had 43%
decreased body weight gain, 21% decreased food consumption and a 150%
increase in uptake of iodine-125.  There was no significant discharge of
radioactive iodine from the thyroid after administration of perchlorate.

The required five lines of evidence to support the threshold mode of
action for thyroid pituitary disruption and rat thyroid tumors are
satisfied in the pyrimethanil studies.

The EPA’s final rule establishing a tolerance for pyrimethanil in wine
stated that “The Agency’s Carcinogenicity Peer Review Committee
(CPRC) chose a non-linear approach (MOE) based on a NOEL of 17 mg/kg/day
for increased incidences of thyroid tumors in rats.  The MOE methodology
was selected because of thyroid tumors associated with administration of
pyrimethanil in the rat, which may be due to a disruption in the
thyroid-pituitary status.  This chemical has been classified as a Group
C chemical (possible human carcinogen) and a non-linear methodology
(MOE) was applied for the estimation of human cancer risk. The estimated
MOE does not exceed the Agency’s level of concern and therefore, EPA
has a reasonable certainty that no harm will result from exposures to
residues of pyrimethanil.”

	6. Neurotoxicity.

a.  Acute Neurotoxicity

Groups of 10 rats/sex/group were dosed once by oral gavage at dose
levels of  0, 30, 100, 1,000 mg of pyrimethanil/kg bodyweight.  On the
day of dosing, high dose animals experienced transient behavioral
effects attributable to receipt of a substantial bolus dose of test
substance.  No histopathological lesions accompanied these transient
behavioral changes.  The NOAEL was 100 mg/kg due to reduced body
temperature for males.  The NOEL was 30 mg/kg.

b.  Subchronic Neurotoxicity

Groups of 12 Sprague-Dawley rats per sex were treated for 13 weeks with
pyrimethanil via the diet  at 0, 4, 38.7-44.3, 391.9-429.9 mg/kg/d
(males and females, respectively).  There were no treatment-related
findings in behavioral assessments, neuropathology or brain
morphometrics.  The NOEL for this study is 38.7 – 44.3 mg/kg/day
(males and females, respectively) based upon decreased body weight and
food consumption in the high dose group.

	6. Animal metabolism. Pyrimethanil is rapidly metabolized and excreted
from lactating dairy cows.  The observed total radioactive residues in
edible tissues and milk were as follows: milk - maximum residue of 0.069
ppm; liver -0.363 ppm; kidney – 0.249 ppm and muscle – 0.017 ppm.
The metabolic pathway is similar to that of plants involving
hydroxylation of the phenyl and pyrimidine rings as well as
hydroxylation of the methyl substituents.  Further metabolic reactions
occur including cleavage of the phenyl ring to produce substituted
pyrimidines.  The major metabolite was AE C614276 (46% of the kidney
residues, 63% of the milk residues) resulting from hydroxylation of the
phenyl ring.  Hydroxylation of the pyrimidinyl ring of pyrimethanil
resulted in formation of minor amounts of AE C614277.  Hydroxylation of
the methyl groups of pyrimethanil resulted in formation of minor amounts
of AE C614278.  Hydroxylation of the methyl groups of AE C614276
resulted in formation of minor amounts of AE C614800.

7. Endocrine disruption. Chronic, life span, and multi-generational
bioassays in mammals and acute and subchronic studies on aquatic
organisms and wildlife did not reveal endocrine effects.  Any endocrine
related effects would have been detected in this definitive array of
required tests.  The probability of any such effect due to agricultural
uses of pyrimethanil is negligible.

C. Aggregate Exposure

1. Dietary exposure.  Amended tolerances are proposed for pyrimethanil
under 40 CFR §180.518 in or on pome fruits following postharvest
thermofog application as well as apple wet pomace, milk, and kidney.
Tolerances are currently established for almonds (0.2 ppm), almond hulls
(12 ppm), apple wet pomace (12 ppm), banana (0.1 ppm), citrus oil (150
ppm), citrus fruits crop group 10 (10 ppm), pome fruit crop group 11 (3
ppm), stone fruit crop group 12, except cherry (3 ppm), grape (5 ppm),
grape raisins (8 ppm), onion dry bulb (0.1 ppm), onion green (2 ppm),
pistachio (0.2 ppm), strawberry (3 ppm), tomato (0.5 ppm), vegetable
subgroup 1C (0.05 ppm), milk (0.03 ppm), kidney of cattle, goat, horse,
sheep (0.3 ppm), and meat, meat by-products and fat of cattle, goat,
horse, sheep (0.01 ppm).  There are no residential uses proposed for
pyrimethanil.  Therefore, potential human risk scenarios cover aggregate
exposure from food residues and drinking water.

i. Food.

Estimates of acute dietary exposure from potential pyrimethanil residues
with the amended (increased) tolerances on pome fruits, milk, and kidney
are all well under 100% of the acute reference dose at the 95th
percentile at tolerance level residues on 100% of the crop treated.
The highest exposed subpopulation of “Children 1-2 years old”
occupied 65% of the acute population reference dose (aRfD) at the aRfD
of 1 mg/kg BW.  Exposures of females in various groups aged 13-50, at
the acute population adjusted dose (aPAD) of 0.45 mg/kg, occupied 20 -
29% of the aPAD., while the US Population utilizes 16.44%.  Secondary
residues for meat and milk were included in the assessment.  These were
calculated using theoretical dietary burdens from sensible diets for
beef and dairy cattle and tissue to feed ratios from the ruminant
feeding study.

Refined chronic dietary exposure estimates resulting from the proposed
tolerance amendments for pyrimethanil are well within acceptable limits
for all population subgroups examined.  Assumptions were that
commodities contained average field residues, percentage crop treated
estimates by EPA, combined mean residue concentrations, high-end pome
fruit residues and all water consumed containing pyrimethanil at the
highest EEC.  The highest exposed groups of “Children 1-2 years” and
“Non-Nursing infants” each utilized approximately 10.0% of the
chronic reference dose (cRfD); the US Population utilized 1.8% of the
cRfD or 0.003020 mg/kg BW.  Compared with the no cancer effect level of
17 mg/kg BW, the margin of exposure was 5,629.  Average anticipated
residue values were calculated from the appropriate field trial studies
conducted for pyrimethanil. The average residue values were adjusted by
the projected market share, (percent crop treated), at product maturity.
Concentration factors derived from processing studies were included
where appropriate.  Secondary residues were calculated using theoretical
dietary burdens derived from sensible diets for beef and dairy cattle
and tissue to feed ratios from the ruminant feeding study.

	ii. Drinking water.

US EPA’s Standard Operating Procedure (SOP) for Drinking Water
Exposure and Risk Assessments was followed to perform the Tier One
drinking water assessment.  This SOP uses a variety of tools to conduct
drinking water assessments, including water models such as SCI-GROW,
FIRST, PRZMS/EXAMS, and monitoring data.  If monitoring data are not
available then the models are used to predict potential residues in
surface and ground water and the highest levels (whether ground or
surface) are assumed to be the drinking water residue.  In the case of
pyrimethanil, monitoring data are not available.  SCI-GROW and FIRST
were used to estimate a drinking water residue.  Calculation of the
Drinking Water Estimated Concentration (DWEC) for surface water for the
worst case pyrimethnail use scenario results in a acute DWEC of 122 ppb
and a chronic DWEC of 37 ppb.  DWLOCs calculated based on the acute and
chronic risk assessments described above are many fold higher than these
conservative DWECs.  The adult acute and chronic DWLOCs are 9,860 ppb
and 5,936 ppb respectively.  Children’s acute and chronic DWLOCs are
2,641ppb and 1,686 ppb respectively.

	2. Non-dietary exposure. Pyrimethanil products are not labeled for
residential uses (food or non-food), thereby eliminating the potential
for residential exposure or non-occupational exposure.

D) Cumulative Effects

Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.” There are no available data to
determine whether pyrimethanil has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment.  Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
pyrimethanil does not appear to form a toxic metabolite produced by
other substances.  For the purposes of the tolerance petition it has
been assumed that pyrimethanil does not have a common mechanism of
toxicity with other substances.

E) Safety Determination

	1. U.S. population.

Using the assumptions and data described above, based on the
completeness and reliability of the toxicity data, it is concluded that
dietary risk from the proposed uses of pyrimethanil are acceptable for
all populations examined.  Chronic exposure for the US Population
utilizes 1.8% (0.003020 mg/kg bw/day) of the chronic reference dose.
Acute exposure for the US Population utilizes 16.44% of the acute
reference dose.

The highest exposed groups of Children 1-2 years” and “Non-Nursing
infants” each utilize approximately 10.0% of the chronic reference
dose (cRfD), and the subpopulation of Children 1-2 years utilizes 65% of
the acute reference dose.  The actual exposures are likely to be much
less as more realistic data and models are developed.  EPA generally has
no concern for exposures below 100% of the RfD (acute or chronic),
because the RfD represents the level at or below which exposure will not
pose appreciable risk to human health.  Drinking Water Levels of
Comparison (DWLOC) for adults both acute (9,860 ppb) and chronic (5,936
ppb) are several orders of magnitude above the conservative Drinking
Water Estimated Concentration (DWEC) for acute (122 ppb) and chronic (37
ppb) worst case scenarios.  Therefore there is a reasonable certainty
that no harm will occur to the US Population from aggregate exposure
(food and drinking water) to residues of pyrimethanil.

		2. Infants and Children.

The relevant toxicity studies as discussed in the toxicology section
above show no extra sensitivity of infants and children to pyrimethanil,
therefore, the FQPA safety factor can be removed.  Using the assumptions
and data described in the exposure section above, it is concluded that
dietary risk from the proposed uses of pyrimethanil are acceptable for
all infant and children sub-populations examined.  The most highly
exposed sub-population was Children 1-2 years for the acute analysis and
Children 1-2 years and  Non-Nursing infants for the chronic analyses.
The percentage of the acute and chronic reference dose utilized was 65%
and 10%, respectively.  All other infant and children populations have
less exposure.   The chronic and acute drinking water levels of concern
for children (1,684 ppb and 2,600 ppb respectively) are well above the
conservative drinking water estimated concentrations for chronic and
acute scenarios.  The chronic DWEC is 37ppb and the acute DWEC is
122ppb.  Therefore, there is a reasonable certainty that no harm will
occur to infants and children from aggregate exposure to residues of
pyrimethanil.

The tolerance amendments proposed for pyrimethanil in or on pome fruits,
apple wet pomace, milk and kidney meets the criteria stipulated in the
Food Quality Protection Act.  These criteria allow for the establishment
of a tolerance if “there is reasonable certainty of no harm will
result from aggregate exposure to the chemical residue including all
anticipated dietary exposures and all other exposures for which there is
reliable information.”  Pace International LLC has shown that there
are adequate margins of safety for infants and children and the general
U.S population.  This conclusion is based upon a very complete and
acceptable database.

F. International Tolerances

Maximum Residue Limits (Codex MRLs) for pyrimethanil have not been
established by the Codex Alimentarius Commission.

 62 Federal Register 63662-63669 (December 2, 1997)

 PAGE  2


[Federal Register Volume 84, Number 202 (Friday, October 18, 2019)]
[Notices]
[Pages 55947-55948]
[FR Doc No: 2019-22787]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-2731-001.
    Applicants: Heritage Stoney Corners Wind Farm I, LLC.
    Description: Compliance filing: Heritage Stoney Corners Wind Farm
I, LLC Change in Status to be effective 10/12/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5146.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER12-421-002.
    Applicants: Heritage Garden Wind Farm I, LLC.
    Description: Compliance filing: Heritage Garden Wind Farm I, LLC
Change in Status Filing to be effective 10/12/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5154.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER19-2417-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Compliance Filing Pursuant to
Commission's September 16, 2019 Order to be effective 9/23/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5060.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER19-2589-001.
    Applicants: Appalachian Power Company, PJM Interconnection, L.L.C.
    Description: Compliance filing: AEP submits compliance filing per
Commission's 9/16/19 Order to be effective 3/6/2019.

    Filed Date: 10/11/19.
    Accession Number: 20191011-5023.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER20-83-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Revisions to OA in compliance with
the Commission's 8/26/2019 Order in EL15-79 to be effective 12/10/2019.
    Filed Date: 10/10/19.
    Accession Number: 20191010-5150.
    Comments Due: 5 p.m. ET 10/31/19.

    Docket Numbers: ER20-84-000.
    Applicants: Evergy Kansas Central, Inc.
    Description: Sec.  205(d) Rate Filing: Notice of Succession, Rate
Schedules & Service Agreements to be effective 12/9/2019.
    Filed Date: 10/10/19.
    Accession Number: 20191010-5152.
    Comments Due: 5 p.m. ET 10/31/19.

    Docket Numbers: ER20-85-000.
    Applicants: Evergy Kansas Central, Inc.
    Description: Sec.  205(d) Rate Filing: Notice of Succession, Cost-
Based Cooperatives to be effective 12/10/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5000.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER20-86-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Notice of Termination of Small Generator
Interconnection Service Agreement No. 410 of Pacific Gas and Electric
Company.
    Filed Date: 10/10/19.
    Accession Number: 20191010-5164.
    Comments Due: 5 p.m. ET 10/31/19.

    Docket Numbers: ER20-87-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Notice of Termination of Small Generator
Interconnection Service Agreement No. 401 of Pacific Gas and Electric
Company.
    Filed Date: 10/10/19.
    Accession Number: 20191010-5172.
    Comments Due: 5 p.m. ET 10/31/19.

    Docket Numbers: ER20-88-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: Dominion Energy SC 2nd
Amended & Restated Interconnection Agreement Filing to be effective 4/
29/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5015.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER20-89-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO-NE and NEPOOL; Fuel
Security Retention Limit Revision to be effective 12/11/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5021.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER20-90-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-10-11_SA 3361 Big
Rivers Electric-Republic T-T to be effective 9/11/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5064.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER20-92-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee, Eversource Energy Service Company (as
agent),Vermont Electric Power Company, Inc.
    Description: Sec.  205(d) Rate Filing: ISO-NE and NEPOOL;
Transmission Planning Improvements to be effective 12/10/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5108.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER20-93-000.
    Applicants: Heritage Stoney Corners Wind Farm I, LLC.
    Description: Compliance filing: Revised MBR and Affiliate Sales
Authorization Compliance Filing to be effective 9/12/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5139.
    Comments Due: 5 p.m. ET 11/1/19.

    Docket Numbers: ER20-94-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2019-10-11 Non-Resource-
Specific System Resource RA Resource Bid Gen Amendment to be effective
10/12/2019.
    Filed Date: 10/11/19.
    Accession Number: 20191011-5156.
    Comments Due: 5 p.m. ET 11/1/19.
    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF20-46-000.
    Applicants: Eco Green Generation LLC.
    Description: Form 556 of Eco Green Generation LLC [Clean Power #4].
    Filed Date: 10/11/19.
    Accession Number: 20191011-5134.
    Comments Due: None Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-22787 Filed 10-17-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 26 (Wednesday, February 8, 2023)]
[Notices]
[Pages 8289-8290]
[FR Doc No: 2023-02680]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-5391 and FDA-2019-E-5421]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SKYRIZI

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for SKYRIZI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by April 10, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 7, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
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by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
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     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 Nos.
FDA-2019-E-5391 and FDA-2019-E-5421 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; SKYRIZI.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     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 Sec.  10.20 (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>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biological product,
SKYRIZI (risankizumab-rzaa). SKYRIZI is indicated for the treatment of
moderate-to-severe plaque psoriasis in adults who are candidates for
systemic therapy or phototherapy. Subsequent to this approval, the
USPTO received patent term restoration applications for SKYRIZI (U.S.
Patent Nos. 8,778,346 and 10,202,448) from Boehringer Ingelheim
International GmbH, and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated December 26, 2019, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of SKYRIZI represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
SKYRIZI is 2,582 days. Of this time, 2,216 days occurred during the
testing phase of the regulatory review period, while 366 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
March 30, 2012. The applicant claims May 10, 2012, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was March 30, 2012,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act: April 23, 2018. FDA has verified the applicant's claim
that the biologic license application (BLA) for SKYRIZI (BLA 761105)
was initially submitted on April 23, 2018.
    3. The date the application was approved: April 23, 2019. FDA has
verified the applicant's claim that BLA 761105 was approved on April
23, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 70 days or 538 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02680 Filed 2-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 120 (Monday, June 23, 2014)]
[Rules and Regulations]
[Page 35495]
[FR Doc No: 2014-14492]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0214]

Safety Zones; Recurring Events in Captain of the Port Duluth
Zone--Duluth Fourth Fest Fireworks

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Safety Zone for the Duluth
Fourth Fest Fireworks in Duluth, MN from 7 p.m. through 11 p.m. on July
4, 2014. This action is necessary to protect spectators during the
Duluth Fourth Fest Fireworks show. During the enforcement period, entry
into, transiting, or anchoring within the safety zone is prohibited
unless authorized by the Captain of the Port Duluth or his designated
on-scene representative.

DATES: The regulations in 33 CFR 165.943(b) will be enforced from 7
p.m. through 11 p.m. on July 4, 2014 for the Duluth Fourth Fest
Fireworks safety zone described in Sec.  165.943(a)(3).

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email LT Judson Coleman, Chief of Waterways
Management, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
for the annual Duluth Fourth Fest Fireworks in 33 CFR 165.943(a)(3)
from 7 p.m. through 11 p.m. July 4, 2014 on all U.S. navigable waters
of the Duluth Harbor Basin Northern Section within a 900-foot radius of
position 46[deg]46'19.00'' N, 092[deg]06'11.00'' W.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Duluth or his
designated on-scene representative. The Captain of the Port's
designated on-scene representative may be contacted via VHF Channel 16.
    This document is issued under authority of 33 CFR 165.943 and 5
U.S.C. 552(a). In addition to this publication in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of the enforcement of this safety zone via Broadcast
Notice to Mariners. The Captain of the Port Duluth or his on-scene
representative may be contacted via VHF Channel 16.

    Dated: June 4, 2014.
A.H. Moore, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2014-14492 Filed 6-20-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Notices]
[Page 4554]
[FR Doc No: 2015-01493]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL00-95-281]

San Diego Gas & Electric Company v. Sellers of Energy and
Ancillary Services Into Markets Operated by the California Independent
System Operator Corporation and the California Power Exchange; Notice
of Compliance Filing

    Take notice that on January 16, 2015, Shell Energy North America
(US), L.P. submitted a compliance filing pursuant to the Commission's
Opinion No. 536.\1\
---------------------------------------------------------------------------

    \1\ San Diego Gas & Elec. Co. v. Sellers of Energy and Ancillary
Services Into Markets Operated by the California Independent System
Operator and the California Power Exchange., 149 FERC ] 61,116
(2014) (Opinion No. 536).
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on February 6, 2015.

    Dated: January 20, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-01493 Filed 1-27-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 22, 2008 (Volume 73, Number 164)]
[Proposed Rules]
[Page 49625]
[DOCID:fr22au08-15]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-OAR-R04-2008-0512-200815 (b); FRL-8706-3]

Approval and Promulgation of Plans; North Carolina; Miscellaneous
Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve revisions to the State
Implementation Plan submitted by the North Carolina Department of
Environment and Natural Resources on behalf of the State of North
Carolina on April 16, 2001, April 4, 2003, and December 14, 2004. The
purpose of these revisions is to require continuous emissions
monitoring systems be used to determine compliance; specify a 24-hour
block averaging time for sulfur dioxide emissions; make a correction to
a cross-reference; provide options for supplying missing data and for
determining heat input; and make several revisions to permit
exemptions. This action is being taken pursuant to section 110 of the
Clean Air Act.
    In the Final Rules Section of this Federal Register, EPA is
approving the State's SIP revision as a direct final rule without prior
proposal because the Agency views this as a noncontroversial submittal
and anticipates no adverse comments. A detailed rationale for the
approval is set forth in the direct final rule. If no adverse comments
are received in response to this rule, no further activity is
contemplated. If EPA receives adverse comments, the direct final rule
will be withdrawn and all public comments received will be addressed in
a subsequent final rule based on this proposed rule. EPA will not
institute a second comment period on this document. Any parties
interested in commenting on this document should do so at this time.

DATES: Written comments must be received on or before September 22,
2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-OAR-
R04-2008-0512 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-OAR-R04-2008-0512,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Nacosta C. Ward, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.
Please see the direct final rule which is located in the Rules section
of this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Ms. Ward can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information see the direct
final rule which is published in the Rules Section of this Federal
Register.

    Dated: August 6, 2008.
Russell L. Wright, Jr.,
Acting Deputy Regional Administrator, Region 4.
 [FR Doc. E8-19191 Filed 8-21-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Notices]
[Pages 66350-66351]
[FR Doc No: 2013-26461]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC13-21-000]

Commission Information Collection Activities (FERC-574); Comment
Request

AGENCY: Federal Energy Regulatory Commission.

ACTION: Comment request.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory
Commission (Commission or FERC) is submitting the information
collection FERC-574, Gas Pipeline Certificates: Hinshaw Exemption, to
the Office of Management and Budget (OMB) for review of the information
collection requirements. Any interested person may file comments
directly with OMB and should address a copy of those comments to the
Commission as explained below. The Commission issued a Notice in the
Federal Register (78 FR 49491, 8/14/2013) requesting public comments.
FERC received no comments on the FERC-574 and is making this notation
in its submittal to OMB.

DATES: Comments on the collection of information are due by December 5,
2013.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0116, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, identified by the Docket No. IC13-21-000, by
either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-574, Gas Pipeline Certificates: Hinshaw Exemption.
    OMB Control No.: 1902-0116.
    Type of Request: Three-year extension of the FERC-574 information
collection requirements with no changes to the reporting requirements.
    Abstract: The Commission uses the information collected under the
requirements of FERC-574 to implement the statutory provisions of
Sections 1(c), 4 and 7 of the Natural Gas Act (NGA).\1\ Natural gas
pipeline companies file applications with the Commission furnishing
information in order to facilitate a determination of an applicant's
qualification for an exemption under the provisions of Section 1(c). If
the Commission grants exemption, the natural gas pipeline company is
not required to file certificate applications, rate schedules, or any
other applications or forms prescribed by the Commission.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 717-717w
---------------------------------------------------------------------------

    The exemption applies to companies engaged in the transportation,
sale, or resale of natural gas in interstate commerce if: (a) They
receive gas at or within the boundaries of the state from another
person at or within the boundaries of that state; (b) such gas is
ultimately consumed in such state; (c) the rates, service and
facilities of such company are subject to regulation by a State
Commission; and (d) that such State Commission is exercising that
jurisdiction. 18 CFR Part 152 specifies the data required to be filed
by pipeline companies for an exemption.
    Type of Respondents: Pipeline Companies
    Estimate of Annual Burden: \2\ The Commission estimates the total
Public Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \2\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.

                             FERC-574--Gas Pipeline Certificates: Hinshaw Exemption
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden     Estimated
              Number of respondents                responses per   Total number      hours per     total annual
                                                    respondent     of responses      response         burden
(A)                                                          (B)     (A) x (B) =             (D)       (C) x (D)
                                                                             (C)
----------------------------------------------------------------------------------------------------------------
1...............................................               1               1              60              60
----------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $4,200 [60
hours * $70/hour \3\ = $4,200].
---------------------------------------------------------------------------

    \3\ FY2013 Estimated Average Hourly Cost per FTE, including
salary + benefits.
---------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: October 30, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-26461 Filed 11-4-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 4, 2009 (Volume 74, Number 106)]
[Notices]
[Page 26851]
[DOCID:fr04jn09-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1183-000]

NaturEner Glacier Wind Energy 2, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

May 28, 2009.
    This is a supplemental notice in the above-referenced proceeding of
NaturEner Glacier Wind Energy 2, LLC's application for market-based
rate authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 18, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-13005 Filed 6-3-09; 8:45 am]

BILLING CODE 6717-01-P