[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5107-5109]
[FR Doc No: 2018-02234]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2428]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Drug Adverse
Event Reporting and Recordkeeping

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
7, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0284.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Animal Drug Adverse Event Reporting and Recordkeeping--21 U.S.C.
360b(l), 21 CFR 510.301, and 514.80

OMB Control Number 0910-0284--Extension

    With regard to adverse events and product/manufacturing defects
associated with approved new animal drugs, section 512(l) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l))
requires applicants with approved new animal drug applications (NADAs)
and abbreviated new animal drug applications (ANADAs) to establish and
maintain records and reports of data relating to experience with uses
of such drug, or with respect to animal feeds bearing or containing
such drug, to facilitate a determination under section 512(e) as to
whether there may be grounds for suspending or withdrawing approval of
the NADA or ANADA under section 512(e) or 512(m)(4). Sections 571(e)(3)
and 512(e)(2) of the FD&C Act (21 U.S.C. 360ccc(e)(3) and 360b(e)(2))
require that applicants with conditionally approved new animal drug
applications (CNADAs) maintain adequate records and make reports in
accordance with a regulation or order issued under section 512(l).
Finally, section 512(m)(5) of the FD&C Act requires an applicant for a
license to manufacture animal feeds bearing or containing new animal
drugs to maintain adequate records and make reports ``as the Secretary
may by general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such records and
reports are necessary in order to enable the Secretary to determine''
whether there may be grounds for suspending or withdrawing approval of
the new animal drug under section 512(e) or a license to manufacture
animal feeds bearing or containing new animal drugs under section
512(m)(4).
    Section 514.80 of our regulations (21 CFR 514.80) sets forth the
recordkeeping and reporting requirements for applicants and
nonapplicants of approved NADAs and ANADAs. Section 510.301 of our
regulations (21 CFR 510.301) sets forth the recordkeeping and reporting
requirements for licensed medicated feed manufacturing facilities.
    Recordkeeping and reporting requirements for applicants of approved
NADAs and ANADAs. Section 514.80 requires applicants to keep records of
and report to us data, studies, and other information concerning
experience with new animal drugs for each approved NADA and ANADA.
Following complaints from animal owners or veterinarians or following
their own detection of a problem, applicants are required to submit
adverse event reports and product defect reports under Sec.
514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) on Form FDA
1932. Form FDA 1932a (the voluntary reporting form) is used by
veterinarians and the general public to submit adverse event reports,
product defects, and lack of effectiveness complaints directly to FDA.
Form FDA 2301 is used by applicants to submit the required transmittal
of periodic reports (Sec.  514.80(b)(4)); special drug experience
reports (Sec.  514.80(b)(5)(i)); promotional material for new animal
drugs (Sec.  514.80(b)(5)(ii)); and distributor statements (Sec.
514.80(b)(5)(iii)). We review the records and reports required in Sec.
514.80 and the voluntary reports to facilitate a determination under
section 512(e) of the FD&C Act as to whether there may be grounds for
suspending or withdrawing approval of the new animal drug. We have made
minor editorial revisions to Form FDA 1932a to clarify how to report
adverse drug events associated with compounded products using that
form. Submitters are already reporting adverse drug events associated
with compounded products on Form FDA 1932a. The clarifications include:
the addition of a new question, ``Is this a compounded product?''; the
addition of a new field to allow the submitter to provide product
strength, ``Strength of Active Ingredient(s)''; modifying the title of
the existing field requesting the name of manufacturer, so that it
reads, ``Name of Manufacturer or Compounding Pharmacy/Compounder of
Suspected Product''; and a request for contact information for the
manufacturer or compounder. We estimate that the revisions will not
change the average amount of time necessary to complete the form.

    Recordkeeping and reporting requirements for applicants of CNADAs.
As noted, sections 571(e)(3) and 512(e)(2) of the FD&C Act require that
applicants for CNADAs maintain adequate records and make reports in
accordance with a regulation or order issued under section 512(l) of
the FD&C Act. Moreover, section 512(l) requires submission of such
information as required ``by general regulation, or by order . . .''
Conditional approval letters explicitly establish an order requiring
the submission of postmarketing information in accordance with the
requirements of Sec.  514.80. Applicants submit adverse event reports
and product defect reports on Form FDA 1932.
    Recordkeeping and reporting requirements for licensed medicated
feed manufacturing facilities. Section 510.301 requires a licensed
medicated feed manufacturer to keep records of and report to us
information concerning experience with animal feeds bearing or
containing approved new animal drugs. Under Sec.  510.301(a), a
licensed medicated feed manufacturer must immediately report to us
information concerning any mixup in the new animal drug or its
labeling; any bacterial or significant chemical, physical, or other
change or deterioration in a drug; and any failure of one or more
distributed batches of a drug to meet the specifications established
for it. Under Sec.  510.301(b), a licensed medicated feed manufacturer
must report to us within 15 working days of receipt of information
concerning any unexpected side effect, injury, toxicity, or sensitivity
reaction or any unexpected incidence or severity thereof, and any
unusual failure of the new animal drug to exhibit its expected
pharmacological activity. OMB initially approved the information
collection provisions of Sec.  510.301 under control number 0910-0012.
That approval was subsequently consolidated into this collection in
2004. We reviewed the records and reports required by Sec.  510.301 to
facilitate a determination as to whether there may be grounds for
suspending or withdrawing approval of the new animal drug under section
512(e) of the FD&C Act, or grounds for revoking a license to
manufacture medicated feed under section 512(m)(4).
    Since the consolidation of the 0910-0012 collection into this
collection in 2004, we have included the estimated number of medicated
feed adverse event reports as part of our estimate of the number of all
mandatory adverse event reports for new animal drugs. To improve the
clarity of our estimates, we have added a row to table 1, on which we
separately report our estimates of medicated feed reports.
    The continuous monitoring of approved NADAs, ANADAs, CNADAs, and
animal feeds bearing or containing new animal drugs affords the primary
means by which we obtain information regarding potential problems with
the safety and efficacy of marketed approved new animal drugs, as well
as potential product/manufacturing problems. Postapproval marketing
surveillance is important because data previously submitted to us may
not be adequate as animal drug effects can change over time and less
apparent effects may take years to manifest.
    Description of respondents: Respondents to this collection of
information are animal drug manufacturers with approved NADAs, ANADAs,
or CNADAs, as well as licensed commercial feed mills and licensed
mixer-feeders.
    In the Federal Register of July 18, 2017 (82 FR 32829), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
                                                  Number of    responses      Total       Average
             Activity                 FDA Form   respondents      per         annual    burden  per  Total hours
                                                               respondent   responses     response
----------------------------------------------------------------------------------------------------------------
Medicated feed reports, Sec.                N/A            5            1            5       * 0.25         1.25
 510.301(a) and (b)...............
Mandatory adverse event reporting,         1932           22           81        1,782            1        1,782
 21 U.S.C. 360b(l); Sec.
 514.80(b)(1); (b)(2)(i) and (ii);
 (b)(3); and (b)(4)(iv)(A)........
Voluntary adverse event reporting         1932a          197            1          197            1          197
 by veterinarians and the general
 public...........................
Periodic drug experience reports,          2301          200         8.11        1,622           16       25,952
 Sec.   514.80(b)(4)..............
Special drug experience reports,           2301          200         0.57          114            2          228
 Sec.   514.80(b)(5)(i)...........
Submission of advertisements and           2301          200        20.12        4,024            2        8,048
 promotional labeling, Sec.
 514.80(b)(5)(ii).................
Submission of distributor                  2301          190          0.1           19            2           38
 statements, Sec.
 514.80(b)(5)(iii)................
                                   -----------------------------------------------------------------------------
    Total.........................  ...........  ...........  ...........  ...........  ...........    36,246.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (15 minutes).

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                             Number of      Total        Average
                 Activity                     Number of     records per     annual      burden per   Total hours
                                            recordkeepers  recordkeeper    records    recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping, Sec.   510.301 \2\.........             5              1            5             4            20
Recordkeeping, 21 U.S.C. 360b(l) and Sec.         646.70           7.19      4,649.8            14        65,097
  514.80(e) \3\...........................
                                           ---------------------------------------------------------------------
Total.....................................  .............  ............  ...........  .............       65,117
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This estimate includes all recordkeeping by licensed medicated feed manufacturers under Sec.   510.301.
\3\ This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and CNADAs under Sec.
  514.80(e).

    We base our reporting and recordkeeping estimates on our experience
with adverse event reporting for approved new animal drugs and the
number of reports received in the previous 3 years. Since the

consolidation of the 0910-0012 collection into this collection in 2004,
we have included the estimated recordkeeping burden for medicated feed
adverse event reports as part of our estimate of the recordkeeping
burden of all mandatory adverse event reports for new animal drugs. To
improve the clarity of our estimates we have added a row to table 2, on
which we separately report our recordkeeping estimate for medicated
feed adverse event reports (20 hours).
    The burden of this collection has changed. There was a slight
increase in the estimated number of reports submitted to FDA under
total annual responses (by 7.8 responses) and there was a slight
overall decrease in burden hours (by 1.75 hours). This minor
fluctuation in responses and hours is due to the normal variation in
the submission of reports to FDA, the correction of mathematical
errors, and a change in reporting methodology (addition of a new row to
table 1 and table 2).
    We continually strive to improve our systems for collecting and
analyzing drug experience reports and adverse event reports. To that
end, we have developed an electronic submission system by which Form
FDA 2301 may be submitted to the Agency. For Form FDA 1932a, we have a
fillable electronic form available online, which can be submitted by
email to FDA Center for Veterinary Medicine. We specifically invite
comment from respondents on the utility of these reporting forms.
Electronic adverse event reporting for approved new animal drugs
(including mandatory reporting under Sec.  514.80(b) and voluntary
reporting) has been approved under OMB control number 0910-0645.
Reporting and recordkeeping associated with the index of legally
marketed unapproved new animal drugs for minor species (21 CFR part
516) is approved under OMB control number 0910-0620.

    Dated: January 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02234 Filed 2-2-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Rules and Regulations]
[Pages 72002-72007]
[FR Doc No: 2016-25293]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0559; FRL-9952-22]

Penflufen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
penflufen in or on vegetable, bulb, group 3-07; beet, sugar, roots; and
beet, sugar, tops. Interregional Research Project Number 4 (IR-4)
requested the tolerance associated with pesticide petition number (PP#)
5E8382, and Bayer CropScience requested the tolerances associated with
PP# 5F8379, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 19, 2016. Objections and
requests for hearings must be received on or before December 19, 2016,
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-2015-0559, 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.

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-2015-0559 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
December 19, 2016. 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-2015-0559, 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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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#
5E8382) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Princeton, NJ 08540. The petition requested that 40 CFR
180.664 be amended by establishing tolerances for residues of the
fungicide penflufen, (1H-Pyrazole-4-carboxamide, N-[2-(1,3-
dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-), in or on onion, bulb, 3-
07A at 0.01 parts per million (ppm); and onion, green, 3-07B at 0.015
ppm. That document referenced a summary of the petition prepared by
Bayer CropScience, the registrant, which is available in the docket
EPA-HQ-OPP-2015-0559-0002 at http://www.regulations.gov.
    In the Federal Register of July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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# 5F8379) by Bayer CropScience, 2 T.W.
Alexander Drive, Research Triangle Park, NC 27709. The petition
requested that 40 CFR 180.664 be amended by establishing tolerances for
residues of the fungicide penflufen, (1H-Pyrazole-4-carboxamide, N-[2-
(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-), in or on beet,
sugar, roots at 0.01 ppm and beet, sugar, tops at 0.01 ppm. That
document referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket EPA-HQ-
OPP-2015-0559-0006 at http://www.regulations.gov.
    Five comments were received in response to the notices of filing.
EPA's responses to these comments are discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the petitioned-for tolerances for subgroups 3-07A and 3-07B
since the Agency has determined that a crop group tolerance for
vegetable, bulb, group 3-07 is more appropriate. The reason for these
changes are explained in Unit IV.D.

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 penflufen including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with penflufen follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The liver and thyroid are target organs for penflufen. No evidence
of quantitative or qualitative susceptibility was seen in developmental
toxicity studies (rats and rabbits). Developmental toxicity was not
observed in the rat or rabbit studies, although the studies did not
test up to the limit dose. However, new studies are not expected to
identify developmental endpoints with points of departure (PODs) lower
than those determined in the current studies. In the reproductive
study, decreased pup weight, delayed vaginal patency, and decreased
brain, spleen, and thymus weights were seen in the presence of limited
maternal effects (body weight changes), suggesting qualitative
sensitivity. However, concern for the sensitivity is low since the
effects are well characterized, and there is a clear NOAEL for the
effects seen. Decreased motor and locomotor activity were observed in
both sexes of rats following acute oral exposure and in female rats
following subchronic oral exposure; neuropathological lesions were not
observed in either study.
    Penflufen is classified as having ``suggestive evidence of
carcinogenicity.'' A statistically significant increase in histiocytic
sarcomas with a positive trend in male rats only (but in the absence of
a dose response and lack of pre-neoplastic lesions) was seen. A
marginal increase in brain astrocytomas was also observed in males at
the high dose; however, this effect was not dose-related, did not reach
statistical significance, and there was no overall trend. In addition,
there were no pre-neoplastic lesions, such as glial proliferations,
which are a good indicator of chemical tumor induction (i.e., there
will be changes in the cells prior to transformation to a neoplasm).
The ovarian adenomas observed at the high dose also showed no dose
response, no pair-wise significance, no decrease in latency, and there
were no pre-neoplastic lesions such as hyperplasia of the epithelial
cells of the endometrium. Additionally, there was no evidence of
carcinogenicity in male or female mice (at doses that were judged to be
adequate to assess the carcinogenic potential), no concern for
mutagenicity (in vivo or in vitro) for the parent molecule or the two
metabolites, and there were no other lines of evidence of
carcinogenicity (such as structure-activity relationship). Although
these three tumors were considered treatment-related, they provided
weak evidence of carcinogenicity due to the marginal nature of the
tumor responses and the other factors mentioned above. Given the weak
evidence indicating any potential for carcinogenicity, EPA has
determined that quantification of risk using a non-linear approach
(i.e., RfD) will adequately account for all chronic toxicity, including
carcinogenicity, which could result from exposure to penflufen. The
NOAEL (38 mg/kg/day) used for establishing the chronic RfD is
approximately 10-fold lower than the dose (approximately 300 mg/kg/day)
that induced a marginal tumor response. The EPA has determined that the
chronic population adjusted dose is protective of all long-term
effects, including potential carcinogenicity, based on limited evidence
for carcinogenicity (histiocytic sarcomas) in male rats. There is no
mutagenicity concern for penflufen. The risk assessments conducted for
penflufen are based on the most sensitive endpoints in the toxicity
database and are protective of all effects observed in the toxicology
database.
    Specific information on the studies received and the nature of the
adverse effects caused by penflufen as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document ``Penflufen.
Human Health Risk Assessment to Support New Uses on Bulb Vegetables
(Crop Group 3-07) and Sugar Beets.'' in pages 8-12 in docket ID number
EPA-HQ-OPP-2015-0559.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the

dose at which no adverse effects are observed (the NOAEL) and the
lowest dose at which adverse effects of concern are identified (the
LOAEL). Uncertainty/safety factors are used in conjunction with the POD
to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for penflufen used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of May 14, 2012 (77 FR 28278) (FRL-
9341-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to penflufen, EPA considered exposure under the petitioned-for
tolerances as well as all existing penflufen tolerances in 40 CFR
180.664. EPA assessed dietary exposures from penflufen in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for penflufen. In estimating acute
dietary exposure, EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID) Version
3.16. This software uses 2003-2008 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA used tolerance-level residues, default
processing factors, and 100 percent crop treated (PCT) for all
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008
food consumption data from the USDA's NHANES/WWEIA. As to residue
levels in food, EPA used tolerance-level residues, default processing
factors, and 100 PCT for all commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has determined that quantification of risk using a non-
linear approach (i.e., cRfD) will adequately account for all chronic
toxicity, including carcinogenicity, which could result from exposure
to penflufen. Cancer risk was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for penflufen. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water.
    In drinking water, the residue of concern is penflufen parent and
its degradates, penflufen-hydroxybutyl (Pen-3HB) and penflufen-
pyrazolyl-AAP (AAP). The Agency used screening level water exposure
models in the dietary exposure analysis and risk assessment for
penflufen in drinking water. These simulation models take into account
data on the physical, chemical, and fate/transport characteristics of
penflufen. Further information regarding EPA drinking water models used
in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated
drinking water concentrations (EDWCs) of penflufen for acute exposures
are estimated to be 5.09 parts per billion (ppb) for surface water and
123 ppb for ground water. The EDWCs of penflufen for chronic exposures
for non-cancer assessments are estimated to be 3.95 ppb for surface
water and 84.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 123 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 84.8 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Penflufen is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    EPA has not found penflufen to share a common mechanism of toxicity
with any other substances, and penflufen does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that penflufen does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable

data available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of quantitative
or qualitative susceptibility was seen in developmental toxicity
studies in rats and rabbits. In the rat and rabbit developmental
toxicity studies, maternal findings were limited to decreased body
weight gain at the highest doses tested (HDT). No adverse effects were
observed in rat or rabbit fetuses. In the rat multi-generation
reproduction study, a slight decrease in litter size, delayed sexual
maturation, decreased body weight and weight gain, and decreased brain,
spleen, and thymus weights were noted in the offspring animals in the
presence of less pronounced maternal toxicity (decreased body weight
and weight gain, alteration in food consumption, decreased thymus
weight, and decreased spleen weights) suggesting qualitative
susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for penflufen is complete.
    ii. There is no concern for neurotoxicity and no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity. Although clinical signs were observed in acute and
subchronic neurotoxicity studies with penflufen, there is a clear NOAEL
for the effects seen and the endpoints and PODs selected for risk
assessment are protective. The NOAELs used for risk assessment are 2x
lower than where clinical signs were observed.
    iii. Although there is some evidence of qualitative sensitivity of
the young in the reproduction study, the effects are well
characterized, and there is a clear NOAEL for effects seen. Also, the
current risk assessments are based on the most sensitive endpoints
derived from studies with NOAELs 5x lower than the doses at which
offspring effects were observed in the reproductive toxicity study.
Thus, the PODs selected for risk assessment are protective of potential
offspring effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to penflufen in drinking water. These assessments
will not underestimate the exposure and risks posed by penflufen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to penflufen will occupy 4.2% of the aPAD for all infants (<1 year
old), the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
penflufen from food and water will utilize 1.2% of the cPAD for all
infants (<2 year old) the population group receiving the greatest
exposure. There are no residential uses for penflufen.
    3. Short- and intermediate-term risk. Short- and intermediate-term
adverse effects were not identified; however, penflufen is not
registered for any use patterns that would result in short- or
intermediate-term residential exposures. Short- and intermediate-term
risks are assessed based on short- and intermediate-term residential
exposures plus chronic dietary exposure, respectively. Because there
are no short- and intermediate-term residential exposures, and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short-term risk), no further assessment of short- or
intermediate-term risks are necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risks for penflufen.
    4. Aggregate cancer risk for U.S. population. EPA assessed cancer
risk using a non-linear approach (i.e., RfD) since it adequately
accounts for all chronic toxicity, including carcinogenicity, that
could result from exposure to penflufen. As the chronic dietary
endpoint and dose are protective of potential cancer effects, penflufen
is not expected to pose an aggregate cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to penflufen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography and triple stage quadrupole mass spectrometry (HPLC/MS/
MS)) is available to enforce the tolerance expression.
    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.
    The Codex has not established a MRL for penflufen.

C. Response to Comments

    One comment was received in response to the Notice of Filing for
PP# 5E8382. The commenter was opposing the use and sale of penflufen in
the United States. The Agency understands the commenter's concerns and
recognizes that some individuals believe that pesticides should be
banned on agricultural crops. However, the existing legal framework
provided by Section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by

that statute. EPA has found that there is a reasonable certainty of no
harm to humans after considering the toxicological studies and the
exposure levels of humans to penflufen.
    Three comments were received in response to the Notice of Filing
for PP# 5F8379. One comment was in support of the Proposed Rule, while
two comments were opposing any tolerance level above 0.00 ppm for any
pesticides used in the U.S. The Agency understands the commenter's
concerns and recognizes that some individuals believe that pesticides
should be banned on agricultural crops. However, the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. In
addition, both commenters indicated that IR-4 and Rutgers University
are profiteering. The IR-4 program was created by Congress in 1963 in
order to assist minor crop growers in the process of obtaining
pesticide registrations. IR-4 National Coordinating Headquarters is
located at Rutgers University in New Jersey and receives the majority
(90%) of its funding from the USDA. It is the only publicly funded
program that conducts research and submits petitions for tolerances.
IR-4 operates in collaboration with USDA, the Land Grant University
System, the agrochemical industry, commodity associations, and EPA. IR-
4 identifies needs, prioritizes accordingly, and conducts research. The
majority (over 80%) of IR-4's research is conducted on reduced-risk
chemicals. Under the Pesticide Registration Improvement Act (PRIA), IR-
4 works in cooperation with the registrant to request an exemption for
the registration services. The exemption may be granted if the
application is solely associated by simultaneous submission with a
tolerance petition in connection with IR-4 and if it is in the public
interest. This fee exemption serves as an incentive to pursue
registration of minor uses supported by the IR-4 program. In addition
to the work done in pesticide registration, IR-4 develops risk
mitigation measures for existing registered products. Therefore, IR-4
and Rutgers University are not profiteering from registering
pesticides.
    A comment was submitted by the Environmental Health Program of the
Center for Biological Diversity and was primarily concerned about
environmental risks and Agency compliance with any relevant obligations
under the Endangered Species Act. This comment is not relevant to the
Agency's evaluation of safety of the penflufen tolerances; section 408
of the FFDCA focuses on potential harms to human health and does not
permit consideration of effects on the environment.

D. Revisions to Petitioned-for Tolerances

    Based on review of the data supporting the petitions, EPA has
revised the petitioned-for tolerance on onion, green, subgroup 3-07B.
Both representative commodities for crop group 3-07 were submitted for
the new uses, which included different tolerances proposed for crop
subgroup 3-07A and 3-07B. Although the petitioner requested separate
tolerances (based on the Organization for Economic Cooperation and
Development (OECD) calculation procedure), EPA has decided to establish
a tolerance for crop group 3-07 at the level of qualification (LOQ) of
the enforcement method (0.01 ppm), because maximum residues from crop
subgroup 3-07A and subgroup 3-07B representative commodities were
within a five-fold difference of each other, and because with residues
in the field trials all less than the LOQ, the OECD calculation
procedure stipulates that the LOQ is the appropriate tolerance level.
Therefore, a single tolerance on the crop group vegetable, bulb, group
3-07 is appropriate.

V. Conclusion

    Therefore, tolerances are established for residues of penflufen, in
or on vegetable, bulb, group 3-07 at 0.01 ppm; beet, sugar, roots at
0.01 ppm; and beet, sugar, tops at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes 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). 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 tolerance 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: September 30, 2016.
Michael Goodis,
Acting 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.  180.664, alphabetically add entries for ``beet, sugar,
roots'', ``beet, sugar, tops'', and ``vegetable, bulb, group 3-07'' to
the table in paragraph (a) to read as follows:

Sec.  180.664  Penflufen; tolerances for residues.

    (a) * * *

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

                                * * * * *
Beet, sugar, roots......................................        0.01 ppm
Beet, sugar, tops.......................................        0.01 ppm

                                * * * * *
Vegetable, bulb, group 3-07.............................        0.01 ppm

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-25293 Filed 10-18-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Notices]
[Pages 26748-26749]
[FR Doc No: 2014-10616]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14578-000]

Telluride Energy, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On January 15, 2014, Telluride Energy, LLC filed an application for
a preliminary permit, pursuant to section 4(f) of the Federal Power
Act, proposing to study the feasibility of the Buchanan Dam
Hydroelectric Project (Buchanan Dam Project or project) at the U.S.
Army Corps of Engineers' (Corps) Eastman Lake and Buchanan dam on the
Chowchilla River, near the city of Chowchilla in Madera County,
California. The sole purpose of a preliminary permit, if issued, is to
grant the permit holder priority to file a license application during
the permit term. A preliminary permit does not authorize the permit
holder to perform any land-disturbing activities or otherwise enter
upon lands or waters owned by others without the owners' express
permission.
    The proposed project would consist of the following: (1) A new
penstock that

would take water from the existing Eastman Lake; (2) a new powerhouse
at the base of the existing Buchanan dam containing a 2.98-megawatt
turbine-generator; (3) a new estimated 0.5-mile-long primary
transmission line connecting the project to Pacific Gas and Electric
Company's transmission lines south of the project; and; (4) appurtenant
facilities. The proposed project would have an estimated average annual
generation of 11,258 megawatt-hours and operate utilizing releases from
Eastman Lake, as directed by the Corps.
    Applicant Contact: Mr. Kurt Johnson, Telluride Energy, LLC, 100
West Colorado, Suite 222, P.O. Box 1646, Telluride, CO 81435; phone:
(970) 729-5051.
    FERC Contact: Shana Murray; 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-14578) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: May 1, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-10616 Filed 5-8-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92923-92925]
[FR Doc No: 2016-30564]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79559; File No. SR-NYSEMKT-2016-115]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Change Modifying the NYSE Amex
Options Fee Schedule

December 14, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on December 1, 2016, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to modify the NYSE Amex Options Fee Schedule
(``Fee Schedule''). The Exchange proposes to implement the fee change
effective December 1, 2016. The proposed change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The purpose of this filing is to amend Section III. C. of the Fee
Schedule to adjust the monthly Rights Fees assessed on Specialists, e-
Specialists, Directed Order Market Markers (each a ``DOMM), and to
provide alternative means to qualify for a discount on the Rights Fees.
The Exchange proposes to implement these changes effective on December
1, 2016.
    Currently, the Exchange charges a Rights Fee on each issue in the
allocation of an e-Specialist, DOMM, and Specialist.\4\ The monthly
Rights Fee ranges from $75 to $1,500 and is based on the Average
National Daily Customer Contracts (``CADV'') per issue. With one
exception, the more active an issue, the higher the Rights Fee
assessed. The exception is that the Exchange currently charges a higher
rate for the lowest-volume issues (i.e., less than 201 CADV) to offset
the Exchange's revenue with the cost of listing and maintaining these
low-volume issues.
---------------------------------------------------------------------------

    \4\ See Fee Schedule, Section III. C. (e-Specialist, DOMM and
Specialist Monthly Rights Fees) (describing how the Rights Fee is
assessed and setting forth the current rates), available here,
https://www.nyse.com/publicdocs/nyse/markets/amex-options/NYSE_Amex_Options_Fee_Schedule.pdf.
---------------------------------------------------------------------------

Proposed Modification to the Rights Fees
    The Exchange proposes to align the Rights Fees with the economic
benefit of being the e-Specialist, DOMM, or Specialist in a given
issue, based on trading activity in an issue. The Exchange therefore
proposes that some rates would decrease (for lower-volume issues) and
others would increase (for higher-volume issues). Using the same CADV
levels currently in place, the Exchange proposes to amend the Rights
Fees as follows:

              e-Specialist, DOMM, and Specialist Rights Fee
------------------------------------------------------------------------
     Average national daily customer
           contracts per issue              Current fee    Proposed fee
------------------------------------------------------------------------
0 to 200................................            $250             $50
201 to 2,000............................              75              60
2,001 to 5,000..........................             200             150
5,001 to 15,000.........................             375             375
15,001 to 100,000.......................             750           1,250
Over 100,000............................           1,500           2,000
------------------------------------------------------------------------

    As shown in the chart above, the Exchange proposes to significantly
decrease the Rights Fee for the lowest-volume issues (i.e., between 0-
200 contracts) to better account for the costs to each e-Specialist,
DOMM, and Specialist, irrespective of costs and revenue to the Exchange
associated with listing an issue. The Exchange also proposes to
slightly decrease the Rights Fee for option issues trading between 201-
2,000 CADV and trading between 2,001-5,000 CADV to better align with
the cost to the Exchange associated with such issues. The Exchange
believes the proposed reduction in the Rights Fee for issues trading
under 5,001 CADV would create an incentive for Specialists and e-
Specialists to request appointments in these lower-volume issues, which
may result in increased liquidity to the benefit of market
participants. Similarly, the Exchange believes the proposed reductions
would encourage DOMMs to seek to transact more in these less active
issues (i.e., to make order flow arrangements with Customers to direct
orders in these issues to them), which in turn should increase volume
on the Exchange.
    In addition, the Exchange proposes to increase the Rights Fees
associated with the two most active CADV categories of issues to better
reflect the economic benefits of being an e-Specialist, DOMM, or
Specialist in more actively-traded issues (i.e., option issues trading
more than 5,000 CADV). The Exchange believes the proposed modifications
to the Rights Fees are appropriate as an e-Specialist, DOMM, or
Specialist would have an opportunity to interact with fewer than 201
contracts per day to cover the proposed $50 per month Rights Fees and
would have the opportunity to interact with more than 100,000 contracts
per day to cover the proposed $2,000 per month Rights Fee.
Proposed Discounts to the Rights Fees
    The Exchange proposes two alternative methods for Specialists, e-
Specialists, and DOMMs to qualify for a discount on the monthly Rights
Fees. First, as proposed, any Specialist, e-Specialist, or DOMM that
participates in the Prepayment Program (outlined in Section I.D. of the
Fee Schedule) would be eligible for a 20% discount to their monthly
Rights Fees. Alternatively, the Exchange proposes that any Specialist,
e-Specialist, or DOMM that achieves one of the Tiers in the Amex
Customer Engagement (``ACE'') Program (outlined in Section I.E. of the
Fee Schedule) would be eligible for a discount on their Rights Fees, as
set forth in the table below.

                           Rights Fee Discount
------------------------------------------------------------------------
                                                            Discount on
                        ACE tier                          rights fees  %
------------------------------------------------------------------------
Base \5\................................................               0
1.......................................................               0
2.......................................................               0
3.......................................................              20
4.......................................................              30
5.......................................................              40
------------------------------------------------------------------------

    In the event that\\ an e-Specialist, DOMM, or Specialist qualified
for both discounts in a given month, only the larger discount would be
applied. For instance, a Specialist in one of the Prepayment Programs
would be eligible to receive a 20% discount on the Rights Fees every
month or, if that same Specialist also qualifies for ACE Tier 4, making
it eligible for a 30% discount in a given month, the Specialist would
receive a 30% discount to the Rights Fees for that month in lieu of the
20% discount.
---------------------------------------------------------------------------

    \5\ The Exchange notes that it is proposing to add a Base Tier
to the ACE Program in a separate fee filing, also for December 1,
2016. Thus, reference to a Base Tier herein is designed to align
with that proposed change. See File No. SR-NYSEMKT-2016-114.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\6\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\7\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed modifications to the Rights
Fees are reasonable, equitable and not unfairly discriminatory for a
number of reasons. First, the Rights Fees apply solely to e-
Specialists, DOMMs, and Specialists (other Market Makers are not
subject to this Fee) and are assessed to account for the enhanced
allocation opportunities and economic benefits that inure to these
market participants. Second, the monthly Rights Fees are directly
related to the number of allocations in the appointment of each e-
Specialist, DOMM, or Specialist, which appointments are completely
voluntary. Any e-Specialist, DOMM, or Specialist can opt to relinquish
any issue in its allocation to reduce its total Rights Fee. In
addition, the proposed Rights Fees would be more closely aligned with
the economic benefit of being e-Specialist, DOMM, or Specialist in a
given issue. For example, an e-Specialist, DOMM, or Specialist would
have an opportunity to interact with fewer than 201 contracts per day
to cover the proposed $50 per month Rights Fee and would have the
opportunity to interact with more than 100,000 contracts per day to
cover the proposed $2,000 per month Rights Fee. Further, e-Specialists,
DOMMs, and Specialists trading issues with similar activity levels
would be subject to the same Rights Fees.
    The Exchange believes the proposed reduction in the Rights Fee for
issues trading under 5,001CADV is reasonable, equitable and not
unfairly discriminatory because it would create an incentive for
Specialists and e-Specialists to request appointments in these lower-
volume issues, which may result in increased liquidity to the benefit
of market participants. Similarly, the Exchange believes the proposed
reductions would encourage DOMMs to seek to transact more in these less
active issues (i.e., to make order flow arrangements with Customers to
direct orders in these issues to them), which in turn should increase
volume on the Exchange.
    The Exchange also believes the proposed discounts on the Rights
Fees available to e-Specialists, DOMMs, and Specialists are reasonable,
equitable and not unfairly discriminatory for a number of reasons.
First, the proposed discounts would reduce the overhead costs of e-
Specialists, DOMMs, and Specialists (by reducing the monthly Rights
Fees), which would, in turn, enhance their ability to provide liquidity
to the benefit of all market participants. Second, because Market
Makers that are not e-Specialists, DOMMs, or Specialists are not
subject to the Rights Fees (as such fees are assessed to account for
the enhanced allocation opportunities and economic benefits that inure
to these market participants), the proposed discount would not
disadvantage Market Makers. In addition, all e-Specialists, DOMMs, and
Specialists (as well as any other Market Makers) are eligible to
participate in the Prepayment Program, which would enable them to
qualify for the proposed 20% discount on the Rights Fees. Further, the
proposed discounts available upon satisfying certain Tiers of the ACE
Program are not discriminatory as they are open to all e-Specialists,
DOMMS, and Specialists, as well as all other Market Makers who may
arrange for ``appointment'' status with an Order Flow Provider
(``OFP'').

    Finally, the Exchange is subject to significant competitive forces,
as described below in the Exchange's statement regarding the burden on
competition.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\8\ the Exchange does
not believe that the proposed rule change would impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange believes that the proposed
modifications on the Rights Fees would not impose an unfair burden on
competition because the proposed Rights Fees would more closely align
with the economic benefit of being e-Specialist, DOMM, or Specialist in
a given issue. Because other Market Makers are not subject to the
Rights Fee, the proposed discount would not disadvantage Market Makers.
Instead, the proposed ACE-related discounts would operate to incent
each e-Specialist, DOMM, or Specialist to achieve higher ACE Tiers to
reduce its own Rights Fee. The Exchange believes that the proposed
discounts would encourage e-Specialists, DOMMs, or Specialists to quote
and trade competitively in their issues and would reduce the burden on
competition among e-Specialists, DOMMs, or Specialists in the most
actively-traded issues because e-Specialists, DOMMs, or Specialists
that achieve the discounts would have reduced overhead.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues. In
such an environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \9\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \10\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \11\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2016-115 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2016-115. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of 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-NYSEMKT-2016-115, and should
be submitted on or before January 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-30564 Filed 12-19-16; 8:45 am]
 BILLING CODE 8011-01-P


WEIGHTED EMISSIONS POTENTIAL ANALYSIS

Introduction

The Weighted Emissions Potential analysis (WEP) was developed as a
screening tool for states to decide which source regions have the
potential to contribute to haze formation at specific Class I areas,
based on both the 2002 and 2018 emissions inventories.  This method does
not produce highly accurate results because, unlike the air quality
model and associated PSAT analysis, it does not account for chemistry
and removal processes.  Instead, it relies on an integration of gridded
emissions data, back trajectory residence time data, a one-over-distance
factor to approximate deposition, and a normalization of the final
results.  Residence time over an area is indicative of general flow
patterns, but does not necessarily imply the area contributed
significantly to haze at a given receptor.  Therefore, users are
cautioned to view the WEP as one piece of a larger, more comprehensive
weight of evidence analysis.

Emissions Data Inputs

The emissions data used were the annual, 36km grid SMOKE-processed,
model-ready emissions inventories provided by the WRAP   HYPERLINK
"http://pah.cert.ucr.edu/aqm/308/"  Regional Modeling Center (RMC) .
The analysis was performed for nine (9) pollutants (maps were generated
for all but the last three):

Sulfur oxides

Nitrogen oxides

Organic carbon

Elemental carbon

Fine particulate matter

Coarse particulate matter

Ammonia

Volatile organic carbon

Carbon monoxide.

The following source categories for each pollutant were identified and
preserved through the analysis:

Biogenic

Natural fire

Point

Area

WRAP oil and gas

Off-shore

On-road mobile

Off-road mobile

Road dust

Fugitive dust

Windblown dust

Anthropogenic fires

Residence Time Inputs

The back trajectory residence times were provided by the WRAP
HYPERLINK "http://coha.dri.edu/index.html"  Causes of Haze Assessment
(COHA) .  The COHA project used NOAA’s HYSPLIT model to generate eight
(8) back trajectories daily for each WRAP Class I area for the entire
five-year baseline period (2000-04).  The major model parameters
selected for this analysis are presented in Table 1.  From these
individual trajectories, residence time fields were generated for
one-degree latitude by one-degree longitude grid cells.  Residence time
analysis computes the amount of time (e.g., number of hours) or percent
of time an air parcel is in a horizontal grid cell.  Plotted on a map,
residence time is shown as percent of total hours in each grid cell
across the domain, thus allowing an interpretation of general air flow
patterns for a given Class I area.  The residence time fields for the
20% worst and best IMPROVE-monitored extinction days were selected for
the WEP analysis to highlight the potential emissions sources during
those specific periods.

Table 1

Back Trajectory Model Parameters Selected for WEP Analysis

Model Parameter	Value

Trajectory duration	192 hours (8 days) backward in time

Top of model domain	14,000 meters

Vertical motion option	used model data

Receptor height	500 meters

Meteorological Field	EDAS and FNL (location dependent)

Integration of Emissions and Residence Time Data

The WEP analysis consisted of weighting the annual gridded emissions (by
pollutant and source category) by the worst and best extinction days
residence times for the five-year baseline period.  To account for
deposition along the trajectories, the result was further weighted by a
one-over-distance factor, measured as the distance in km between the
centroid of each emissions grid cell and the centroid of the grid cell
containing the Class I area monitoring site under investigation.  (The
“home” grid cell of the monitoring site was weighted by one fourth
of the 36km grid cell distance, or one-over-9km, to avoid a large
response in that grid cell.)  The resulting weighted emissions field was
normalized by the highest grid cell to ease interpretation.

An example series of maps illustrating the WEP analysis is presented in
Figure 1.  This example shows the annual emissions for NOx across the
domain, the specific residence time pattern for the 20% worst monitored
days at a Class I area, and the resulting weighted emissions map.  Both
the 2002 and 2018 cases are presented.  Interpretation of the results
should focus on which grid cells (or larger regions) have significant
potential to affect the Class I area, and on changes between 2002 and
2018.

An example of associated bar charts showing the estimated contribution
by source category and region is presented in Figure 2.  It is important
to note that these charts show normalized values with no direct
connection to original emissions values.  Interpretation of the results
should focus on the relative contributions by each source category and
region, and the changes between 2002 and 2018.

Caveats

The WEP is not a rigorous, stand-alone analysis, but a simple,
straightforward use of existing data.  As such, there are several
caveats to keep in mind when using WEP results as part of a
comprehensive weight of evidence analysis:

This analysis does not take into account any emissions chemistry.

While actual emissions may vary considerably throughout the year, this
analysis pairs up annual emissions data with 20% worst/best extinction
days residence times – this is likely most problematic for carbon and
dust emissions, which can be highly episodic.

Coarse particle and some fine particle dust emissions tend not to be
transported long distances due to their large mass.

The WEP results are unitless numbers, normalized to the largest-valued
grid cell.  Effective use of these results requires an understanding of
actual emissions values and their relative contribution to haze at a
given Class I area.

2002 NOx Emissions (TPY)

2018 NOx Emissions (TPY)	Residence Time Field, Worst 20% Monitored Days
(2000-2005)	2018 NOx Emissions Weighted by Residence Time and
One-Over-Distance

Figure 1.  Example series of maps for WEP analysis at Bridger
Wilderness, WY.  From left to right:  single-year annual emissions
density map; five-year residence time map; emissions weighted by
residence time, by one-over-distance, and normalized to the highest grid
cell.  Top row presents 2002 results, bottom row presents 2018 results.

Figure 2.  Example source category bar charts based on WEP analysis at
Bridger Wilderness, WY.  Top chart presents 2002 results, bottom chart
presents 2018 results.

 PAGE

 PAGE   1


[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Notices]
[Pages 29178-29179]
[FR Doc No: 2014-11766]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-876-000.
    Applicants: Leaf River Energy Center LLC.
    Description: Leaf RIver Energy Center LLC--Purchase Offer Show
Cause Order Compliance Filing to be effective 7/1/2014.
    Filed Date: 5/14/14.
    Accession Number: 20140514-5080.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-877-000.
    Applicants: Northwest Pipeline LLC.
    Description: Compliance--Order to Show Cause to be effective N/A.

    Filed Date: 5/14/14.
    Accession Number: 20140514-5083.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-878-000.
    Applicants: Arlington Storage Company, LLC.
    Description: Capacity Release Purchase Offer Posting Show Casue
Order Compliance Filing to be effective 12/31/9998.
    Filed Date: 5/14/14.
    Accession Number: 20140514-5102.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-879-000.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Capacity Release Purchase Offer Posting Show Cause
Order Compliance Filing to be effective 12/31/9998.
    Filed Date: 5/14/14.
    Accession Number: 20140514-5116.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-880-000.
    Applicants: Golden Triangle Storage, Inc..
    Description: Docket No. RP14-442-000 Compliance Filing to be
effective 6/17/2014.
    Filed Date: 5/14/14.
    Accession Number: 20140514-5123.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-881-000.
    Applicants: Vector Pipeline L.P.
    Description: Compliance Filing to Show Cause Order RP14-442-000 to
be effective N/A.
    Filed Date: 5/15/14.
    Accession Number: 20140515-5001.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-882-000.
    Applicants: Carolina Gas Transmission Corporation.
    Description: FERC Show cause Order 3-20-14 to be effective 5/22/
2014.
    Filed Date: 5/15/14.
    Accession Number: 20140515-5018.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-883-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance to Show Cause to be effective 6/14/2014.
    Filed Date: 5/15/14.
    Accession Number: 20140515-5025.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-884-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: May2014 Termination of Non-conforming Agreement to be
effective 6/15/2014.
    Filed Date: 5/15/14.
    Accession Number: 20140515-5026.
    Comments Due: 5 p.m. ET 5/27/14.

    Docket Numbers: RP14-885-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Compliance to Show Cause Order to be effective 6/14/
2014.
    Filed Date: 5/15/14.
    Accession Number: 20140515-5029.
    Comments Due: 5 p.m. ET 5/27/14.

    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.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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: Thursday, May 15, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-11766 Filed 5-20-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45244-45245]
[FR Doc No: 2011-19088]

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

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: ER10-2269-001, ER10-2285-001; ER10-2270-001; ER10-
2271-001; ER10-2301-001; ER10-2272-001; ER10-2273-001; ER10-2306-001.
    Applicants: New York State Electric & Gas Corp., Rochester Gas &
Electric Corporation, Central Maine Power Company, Hartford Steam
Company, Carthage Energy, LLC, PEI Power II, LLC, Energetix, Inc.,
NYSEG Solutions, Inc.
    Description: Notice of Non-Material Change in Status of Iberdrola
USA Companies.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5206.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER10-3142-001, ER10-3145-001, ER10-3147-001, ER10-
3148-001, ER10-3114-001, ER10-3116-001, ER10-3118-001, ER10-3120-001,
ER10-3121-001, ER11-2036-001, ER10-3126-001, ER10-3128-001, ER10-3131-
001, ER10-1800-001, ER10-3136-001, ER11-2701-002.
    Applicants: Mountain View Power Partners, LLC, Indianapolis Power &
Light Company, AES Eastern Energy, LP, AES Energy Storage, LLC, AES
Alamitos, LLC, AES Redondo Beach, LLC, Condon Wind Power, LLC, AES
Huntington Beach, L.C., AES Armenia Mountain Wind, LLC, AES Creative
Resources, L.P., AES ES Westover, LLC, AES Ironwood, LLC, AES Red Oak,
L.L.C., AES Laurel Mountain, LLC, AEE2, LLC, Mountain View Power
Partners IV, LLC.
    Description: Supplemental Information to triennial market power
analysis of AEE2, LLC, et al.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5083.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-3769-001.
    Applicants: WSPP Inc.
    Description: WSPP Inc. submits tariff filing per 35.17(b):
Amendment to Incorporation of Rate Schedule into WSPP Agreement (Westar
Energy) to be effective 6/1/2011.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5081.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-3979-002.
    Applicants: PJM Interconnection, LLC, Midwest Independent
Transmission System Operator, Inc.
    Description: PJM Interconnection, LLC submits tariff filing per 35:
Errata to Compliance Filing in Docket No. ER11-3979 correcting Att 2
Sec 6.6 to be effective 6/16/2011.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5128.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4082-000.
    Applicants: Southwestern Public Service Company.
    Description: Southwestern Public Service Company submits tariff
filing per 35.13(a)(2)(iii: 7-20-11--RS114 SPS-Central Valley to be
effective 10/1/2010.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5000.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4083-000.
    Applicants: Southwestern Public Service Company.
    Description: Southwestern Public Service Company submits tariff
filing per 35.13(a)(2)(iii: 7-20-11--RS115 SPS-Farmers to be effective
10/1/2010.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5002.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4084-000.
    Applicants: Southwestern Public Service Company.
    Description: Southwestern Public Service Company submits tariff
filing per 35.13(a)(2)(iii: 7-20-11--RS116 SPS-Lea County to be
effective 10/1/2010.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5003.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4085-000.
    Applicants: Southwestern Public Service Company.
    Description: Southwestern Public Service Company submits tariff
filing per 35.13(a)(2)(iii: 7-20-11--RS117 SPS-Roosevelt to be
effective 10/1/2010.

    Filed Date: 07/21/2011.
    Accession Number: 20110721-5004.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4087-000.
    Applicants: Alabama Power Company.
    Description: Alabama Power Company submits tariff filing per
35.13(a)(2)(iii: 2011 Hartford NITSA Filing to be effective 7/1/2011.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5050.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4088-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits tariff filing per
35.13(a)(2)(iii: Queue Position No. W3-123? Original Service Agreement
No. 2970 to be effective 6/21/2011.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5084.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4089-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits tariff filing per 35.13(a)(2)(iii:
BPA NITSA (UIUC) to be effective 10/1/2011.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5113.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4090-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii: City of Ukiah WPA and NCPA IA to be effective 7/
22/2011.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5127.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Docket Numbers: ER11-4091-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company submits tariff filing
per 35.13(a)(2)(iii: New, Amended, and Cancelled Exhibit B's in APS
Rate Schedule No. 217 to be effective 9/19/2011.
    Filed Date: 07/21/2011.
    Accession Number: 20110721-5140.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 11, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    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 proceedings 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>.

    Dated: July 22, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-19088 Filed 7-27-11; 8:45 am]
BILLING CODE 6717-01-P