[Federal Register Volume 77, Number 122 (Monday, June 25, 2012)]
[Proposed Rules]
[Pages 37859-37862]
[FR Doc No: 2012-15476]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2012-0168; FRL-9692-2]

Approval and Promulgation of Air Quality Implementation Plans;
Utah; Revisions to UAC Rule 401--Permit: New and Modified Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve State Implementation Plan (SIP)
revisions submitted by the State of Utah on April 17, 2008 and
partially approve SIP revisions submitted by the State of Utah on
September 15, 2006. The revisions contain new rules in Utah's Title 307
Rule 401 (Permit: New and Modified Sources). The intended effect of
this action is to propose to approve the rules that are consistent with
the Clean Air Act (CAA.) This action is being taken under sections 110
and 112 of the CAA.

DATES: Comments must be received on or before July 25, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2012-0168, by one of the following methods:
     www.regulations.gov. Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Carl Daly, Director, Air Program, Environmental
Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street,
Denver, Colorado 80202-1129.
     Hand Delivery: Carl Daly, Director, Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129. Such deliveries are only
accepted Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding
Federal holidays. Special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2012-0168. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA, without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm. For additional
instructions on submitting comments, go to Section I. General
Information of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly-available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129. EPA requests that if at all possible, you
contact the individual listed in the FOR FURTHER INFORMATION CONTACT
section to view the hard copy of the docket. You may view the hard copy
of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kevin Leone, Air Program, Mailcode 8P-
AR, Environmental Protection Agency, Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129,<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
II. Background
III. What Authorities Apply to EPA's Proposed Action
IV. EPA's Analysis and Proposed Action on SIP Revisions
V. Summary of Proposed Actions
VI. Statutory and Executive Order Reviews

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials HAP mean or refer to Hazardous Air Pollutant.
    (iv) The initials MACT mean or refer to Maximum Achievable Control
Technology.
    (v) The initials NAAQS mean or refer to National Ambient Air
Quality Standards.
    (vi) The initials NSR mean or refer to New Source Review.
    (vii) The initials SIP mean or refer to State Implementation Plan.
    (viii) The words State or Utah mean the State of Utah, unless the
context indicates otherwise.
    (ix) The initials UAC mean or refer to the Utah Administrative
Code.

I. General Information

A. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    b. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    On September 20, 1999, the State of Utah submitted a renumbering
and recodification of its Utah Administrative Code (UAC) rules within
the Utah SIP. EPA took final action to approve portions of this
submittal on February 13, 2006 (71 FR 7670). In that action EPA
approved the recodification of R307-413-7 (Exemption from Notice of
Intent Requirements for Used Oil Burned for Energy Recovery, previously
found under R307-7-2 and 3). On September 15, 2006, the State of Utah
again submitted a renumbering and recodification of its UAC rules
within the Utah SIP which renumbered R307-413-7 to R307-401-14 (Used
Oil Burned for Energy Recovery). We are proposing to approve this
renumbering in this action.
    On April 17, 2008, the State of Utah submitted a revision to R307-
401-14 which changed the definition of ``Boiler.'' We are proposing to
approve this definition change in this action.
    On October 1, 1990, R307-6 (De minimis Emissions from Air Strippers
and Soil Venting Projects) was approved into the Utah SIP. On August
14, 1998, EPA approved revisions to R307-6 (63 FR 43624). On January 8,
1999, Utah submitted substantive revisions to R307-6, which also
renumbered R307-6 to R307-413-8 and R307-413-9. EPA did not act on this
submittal. On September 15, 2006, Utah submitted revisions which moved
R307-413-8 and R307-413-9 to R307-401-15 (Air Strippers and Soil
Venting Projects) and R307-401-16 (De minimis Emissions from Soil
Aeration Projects). Utah's January 8, 1999, submittal is superceded by
the September 15, 2006, submittal. EPA is proposing to conditionally
approve R307-401-15 and approve R307-401-16 as submitted on September
15, 2006, in this action.
    All other portions of the September 15, 2006, submittal not
addressed in this action will be addressed at a later date.

III. What Authorities Apply to EPA's Proposed Action

    Section 110(l) of the CAA states, ``Each revision to an
implementation plan submitted by a State under this Act shall be
adopted by such State after reasonable notice and public hearing. The
Administrator shall not approve a revision to a plan if the revision
would interfere with any applicable requirement concerning attainment
and reasonable further progress (as defined in section 171), or any
other applicable requirement of this Act.''
    The states' obligation to comply with each of the National Ambient
Air Quality Standards (NAAQS) is considered as ``any applicable
requirement(s) concerning attainment.'' A demonstration is necessary to
show that this revision will not interfere with attainment or
maintenance of the NAAQS, including those for ozone, particulate
matter, carbon monoxide, sulfur dioxide, lead, nitrogen oxides or any
other requirement of the Act.
    The CAA at section 110(a)(2)(C) requires states to include a minor
New Source Review (NSR) program in their SIP to regulate modifications
and new construction of stationary sources within the area as necessary
to assure the NAAQS are achieved. EPA's implementing regulations at 40
CFR 51.160-164 are intended to ensure that new source growth is
consistent with maintenance of the NAAQS and 40 CFR 51.160(e) requires
states to identify types and sizes of facilities which will be subject
to review under their minor NSR program. For sources identified under
40 CFR 51.160(e), section 51.160(a) requires that the SIP include
legally enforceable procedures that enable a state or local agency to
determine whether construction or modification of a facility, building,
structure or installation, or combination of these will result in a
violation of applicable portions of the control strategy; or
interference with attainment or maintenance of a national standard in
the state in which the proposed source (or modification) is located or
in a

neighboring state. Section 110(i) of the CAA specifically precludes
states from changing the requirements of the SIP except through SIP
revisions approved by EPA. SIP revisions will be approved by EPA only
if they meet all requirements of section 110 of the CAA and the
implementing regulations at 40 CFR part 51. See CAA section 110(l); 40
CFR 51.104.
    EPA recognizes that, under the applicable Federal regulations,
states have broad discretion to determine the scope of their minor NSR
programs as needed to attain and maintain the NAAQS. The states have
significant discretion to tailor minor NSR requirements that are
consistent with the requirements of 40 CFR part 51. States may also
provide a rationale for why the rules are at least as stringent as the
40 CFR part 51 requirements where the revisions are different from
those in 40 CFR part 51. For example, states may exempt from minor new
source review certain categories of changes based on de minimis or
administrative necessity grounds in accordance with the criteria set
out in Alabama Power Co. v. Costle, 636 F.2d 323, 360-361 (D.C. Cir.
1979). De minimis sources are presumed not to have an impact and their
emissions would not prevent or interfere with attainment of the NAAQS,
even within nonattainment areas.
    Since there are no ambient air quality standards for air toxics,
the area's compliance with any applicable maximum achievable control
technology (MACT) standards, as well as any Federal mobile source
control requirements under CAA sections 112 or 202(l) would constitute
an acceptable demonstration of noninterference for air toxics. A
revision to the SIP cannot interfere with any federally mandated
program such as a MACT standard (or related section 112 requirements).

IV. EPA's Analysis and Proposed Action on SIP Revisions

    In this proposed rulemaking, we are proposing to approve the
renumbering of R307-413-7 to R307-401-14 (Used Oil Burned for Energy
Recovery) as submitted by the State of Utah on September 15, 2006,
because this provision had been previously approved into the Utah SIP
(71 FR 7670) and the revision does not contain substantive changes to
the rule. We are also clarifying that R307-401-14(3) refers to the
owner or operator of a boiler as described in R307-401-14(1).
    We are proposing to approve changes to the definition of ``Boiler''
in R307-401-14(1) as submitted by the State of Utah on April 17, 2008,
in this action. The current federally approved definition of ``Boiler''
in R307-413-7 references Utah's solid and hazardous waste definition of
``Boiler'' in R315-1-1 as it was defined in 40 CFR 260.10, as amended
on July 1, 2002. Utah's current federally approved version of R315-1-1
incorporates by reference 40 CFR 260.10, as amended on July 1, 2008.
Since there is no substantive difference between 40 CFR 260.10, as
amended on July 1, 2002, and 40 CFR 260.10, as amended on July 1, 2008,
we are proposing to approve this definition change in R307-401-14.
    We are proposing to conditionally approve R307-401-15 and approve
R307-401-16 as submitted on September 15, 2006, in this action. We are
proposing to conditionally approve R307-401-15 because R307-401-15(3)
allows for ``test or monitoring method approved by the executive
secretary,'' which is director's discretion. Utah submitted a letter to
EPA on February 24, 2012, committing to revise R307-401-15(3) to remove
the executive secretary's discretion to approve alternate test or
monitoring methods (see docket). Utah must submit a SIP revision to
change or remove this language not later than one year after the date
of final publication of this rulemaking. If, however, Utah does not
submit such a revision within this timeframe, EPA's conditional
approval of R307-401-15(3) will revert to a disapproval.
    R307-401-15 and R307-401-16 allows all air stripper, soil venting
and soil aeration projects to be exempt from notice of intent and
approval order requirements if the estimated actual air emissions from
volatile organic compounds from a given project are less than 5 tons
per year (R307-401-9(1)(a)) and the level of any one hazardous air
pollutant (HAP) or combination of HAPs is less than the levels listed
in R307-410-4(1)(d) (Toxic Screening Levels and Averaging Periods). EPA
has approved similar de minimis thresholds for criteria pollutants in
past rulemakings: The State of Idaho's permit to construct regulations,
which were approved final on January 16, 2003 (68 FR 2217); and the
State of Montana's exclusion for de minimis changes, which were
approved final on February 13, 2012 (77 FR 7531). R307-401-15 and R307-
401-16 contain provisions which are smaller in nature and scope than
the previously approved rulemakings, as they generally only apply to
the remediation of underground storage tanks. EPA finds the revisions
would not interfere with any applicable requirement concerning
attainment of the NAAQS, rate of progress and reasonable further
progress (as defined in section 171), or any other applicable
requirement of this Act.
    A review of air stripper, soil venting and soil aeration projects
from 2008-2010 which were exempted from notice of intent and approval
order requirements under R307-401-15 and R307-401-16 show negligible
criteria pollutant emissions (see docket). In addition, data from the
Utah leaking underground storage tank program shows a significant
decrease in the number of new cleanups initiated over the last 10 years
(see docket). These provisions meet the requirements of 40 CFR 51.160
because they require prior written approval (R307-401-15(2), R307-401-
16(1)) of the State and have testing requirements (R307-401-15(3)) to
ensure that exempted projects do not exceed the de minimis thresholds
as described in R307-401-9.

V. Summary of Proposed Actions

    Based on the above discussion, EPA finds that the revisions are
consistent with all CAA requirements. We are proposing to approve the
renumbering of R307-413-7 to R307-401-14 (Used Oil Burned for Energy
Recovery) as submitted by the State of Utah on September 15, 2006;
changes to the definition of ``Boiler'' in R307-401-14(1), as submitted
by the State of Utah on April 17, 2008; and conditionally approve R307-
401-15 and approve R307-401-16 as submitted on September 15, 2006.

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities

under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 6, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: June 7, 2012.
Howard M. Cantor,
Acting Regional Administrator, Region 8.
[FR Doc. 2012-15476 Filed 6-22-12; 8:45 am]
BILLING CODE P


[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58295-58296]
[FR Doc No: 2013-23004]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RD13-3-000]

Commission Information Collection Activities (FERC-725A); Comment
Request

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Comment request.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory
Commission (Commission or FERC) is submitting the information
collection FERC-725A, Mandatory Reliability Standards for the Bulk
Power System, to the Office of Management and Budget (OMB) for review
of the information collection requirements. Any interested person may
file comments directly with OMB and should address a copy of those
comments to the Commission as explained below. The Commission solicited
public comments on the information collection analysis associated with
its approval of Reliability Standard EOP-004-2, in an order published
in the Federal Register (78 FR 420064, 7/15/2013).\1\ FERC received no
comments in response to that solicitation and is making this notation
in its submission to OMB.
---------------------------------------------------------------------------

    \1\ North American Electric Reliability Corp., 143 FERC ]61,252
(2013).

DATES: Comments on the collection of information are due by October 23,
---------------------------------------------------------------------------
2013.

ADDRESSES: Comments filed with OMB, identified by collection FERC-725A,
should be sent via email to the Office of Information and Regulatory
Affairs<EMAIL_ADDRESS>Attention: Federal Energy Regulatory
Commission Desk Officer. The Desk Officer may also be reached via
telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, identified by the Docket No. RD13-3-000, by
either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

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

SUPPLEMENTARY INFORMATION:
    Title: FERC-725A, Mandatory Reliability Standards for the Bulk
Power System.
    OMB Control No.: 1902-0244.
    Type of Request: Three-year approval of the FERC-725A information
collection requirements.
    Abstract: The change in this information collection relates to
FERC-approved Reliability Standard EOP-004-2--Event Reporting. Rather
than creating entirely new obligations to report a system disturbance,
the revised Reliability Standard, EOP-004-2, primarily clarifies the
thresholds that can trigger a reporting obligation, and reduces the
reporting burden for certain individual respondents due to the use of a
simplified form in Attachment 2. However, the revised Reliability
Standard would increase the reporting burden for some individual
entities, because it would apply for the first time to transmission
owners and generator owners. We do not anticipate a large increase in
the number of respondents because the existing Reliability Standard
applies to transmission operators and generator operators, which
includes the majority of the entities registered as transmission owners
and generator owners.
    Our estimate below regarding the number of respondents is based on
the NERC compliance registry as of March 2013. According to the
registry, there are 7 transmission owners that are not also
transmission operators, 128 generator owners that are not also
generator operators, and 101 distribution providers that are not also
registered as another functional entity covered by the current event
reporting standards. Thus, we estimate that a total of 236 entities may
be subject to the event reporting requirements of EOP-004-2 for the
first time.\2\
---------------------------------------------------------------------------

    \2\ Although distribution providers are included as responsible
entities under the revised Reliability Standard, their reporting
obligations will be de minimis, as explained in the Guidelines and
Technical Basis attached to the revised standard. See NERC Petition,
Ex. B at 13, Docket No. RD13-3-000 (Dec. 31, 2012). For purposes of
this analysis, however, we included distribution providers as part
of the assumed number of reports per year.
---------------------------------------------------------------------------

    The number of annual reports required could vary widely based on
the individual entity and the extent of its facilities. The estimate
below is based on an assumption that, on average, 25 percent of the
entities covered by EOP-004-2 will have one reportable event per year.
As demonstrated below, the primary increase in cost associated with the
revised standard is expected in Year 1, when newly covered entities
must develop an operating plan for reporting. In Years 2 and 3, an
overall reduction in reporting and recordkeeping burden is expected,
due to the simplified reporting form.
    Type of Respondents: Reliability Coordinator, Balancing Authority,
Transmission Owner, Transmission Operator, Generator Owner, Generator
Operator, and Distribution Provider.\3\
---------------------------------------------------------------------------

    \3\ These entity types are contained in the North American
Electric Reliability Corporation's compliance registry. See http://
www.nerc.com/page.php?cid=3[bond]25 for more information.
---------------------------------------------------------------------------

    Estimate of Annual Burden:\4\
---------------------------------------------------------------------------

    \4\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Number of                    Average burden     Estimated
       Type of  respondent              Reporting/          Number of     responses per   Total number      hours per     total annual   Estimated total
                                   recordkeeping  req't    respondents     respondent     of responses      response         burden        annual cost
                                                                    (A)             (B)     (A)x(B)=(C)          (D)         (C)x(D)         (see below)
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Entities (GO, TO, DP)........  Developing Operating             236               1             236            8           1,888        $113,280.00
                                    Plan (Yr 1 Only).
                                   Reporting Event (Yr               59               1              59            0.17           10.03          601.80
                                    1, 2, and 3).
Entities Subject to Existing       Conforming Operating            1164               1            1164            2           2,328         139,680.00
 Reporting Requirements.            Plan to New
                                    Thresholds (Yr 1
                                    Only).
                                   Reporting Event                  291               1             291           -0.33          -96.03       (5,761.80)
                                    (using new form)
                                    (Yrs 1, 2, and 3).
    Total for Year 1 \5\.........  ....................  ..............  ..............  ..............  ..............        4,130            247,800
    Total for each of Years 2 & 3  ....................  ..............  ..............  ..............  ..............      -86 \6\             (5,160)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The estimated breakdown of annual cost is as follows:

 Year 1
    [cir] New Entities, Development of Operating Plan: 236 entities * 1
response/entity * (8 hours/response * $60/hour \7\) = $113,280.
---------------------------------------------------------------------------

    \5\ Year 1 costs include implementation costs for entities that
must comply with the standard for the first time, plus the cost for
entities that are currently subject to NERC event reporting
requirements to review and make changes to their existing plans. The
Year 1 total also includes the savings from the reduction in
reporting time due to the new Event Reporting Form.
    \6\ In the Order approving the EOP Reliability Standard we
incorrectly used ``-81'' in this cell.
    \7\ For the burden categories above, the estimated hourly loaded
cost (salary plus benefits) for an engineer was assumed to be $60/
hour, based on salaries as reported by the Bureau of Labor
Statistics (BLS) (http://bls.gov/oes/current/naics2_22.htm). Loaded
costs are BLS rates divided by 0.703 and rounded to the nearest
dollar (http://www.bls.gov/news.release/ecec.nr0.htm).
---------------------------------------------------------------------------

    [cir] New Entities, Event Reporting: 59 entities * 1 response/
entity * (.17 hours/response * $60/hour) = $601.80.
    [cir] Current Responsible Entities, Conforming Operating Plan: 1164
entities * 1 response/entity * (2 hours/response * $60/hour) =
$139,680.
    [cir] Current Responsible Entities, Event Reporting Using New Event
Reporting Form: 291 entities * 1 response/entity * [(.17 hours/
response--.5 hours/response) \8\ * $60/hour] = ($5,761.80).
---------------------------------------------------------------------------

    \8\ It is estimated that the average time to complete the
required event report under Reliability Standard EOP-004-1 is 30
minutes, versus an estimated 10 minutes under Reliability Standard
EOP-004-2.
---------------------------------------------------------------------------

 Year 2 and ongoing
    [cir] New Entities, Using ``Event Reporting Form'': 59 entities * 1
response/entity * (.17 hours/response * $60/hour) = $601.80.
    [cir] Old Entities, Using ``Event Reporting Form'': 291 entities *
1 response/entity * [(.17 hours/response--.5 hours/response) * $60/
hour] = ($5,761.80).

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

    Dated: September 16, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-23004 Filed 9-20-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 6, 2008 (Volume 73, Number 152)]
[Notices]
[Page 45755-45756]
[DOCID:fr06au08-54]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EG08-53-000, etc.]

Wessington Wind I, LLC, et al.; Notice of Effectiveness of Exempt
Wholesale Generator Status

July 31, 2008.

------------------------------------------------------------------------
                                                            Docket No.
------------------------------------------------------------------------
Wessington Wind I, LLC..................................     EG08-53-000
Airtricity Pyron Wind Farm, LLC.........................     EG08-54-000
Airtricity Indale Wind Farm, LLC........................     EG08-55-000
Airtricity Panther Creek Wind Farm, LLC.................     EG08-56-000
Wolf Ridge Wind, LLC....................................     EG08-57-000
West Valley Leasing Company LLC.........................     EG08-58-000
Winnebago Windpower LLC.................................     EG08-59-000

Sheldon Energy LLC......................................     EG08-60-000
Gunsight Mountain Wind Energy, LLC......................     EG08-61-000
Willow Creek Energy, LLC................................     EG08-62-000
Valencia Power, LLC.....................................     EG08-64-000
CER Generation II, LLC..................................     EG08-65-000
Tvolumne Wind Project, LLC..............................     EG08-66-000
CPV Maryland, LLC.......................................     EG08-67-000
Montgomery L'Energia Power Partners LP..................     EG08-68-000
Silver Star I Power Partners, LLC.......................     EG08-69-000
------------------------------------------------------------------------

Notice of Effectiveness of Exempt Wholesale Generator Status

    Take notice that during the month of June 2008, the status of the
above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR
366.7(a).

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-18006 Filed 8-5-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Rules and Regulations]
[Pages 36787-36790]
[FR Doc No: 2016-13517]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Rules
and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 556, and 558

[Docket No. FDA-2016-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during March and April 2016. FDA is also
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to reflect changes of
sponsorship of applications and the voluntary withdrawals of approval
of applications that occurred in January and February.

DATES: This rule is effective June 8, 2016 except for the amendments to
21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are
effective June 20, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during March and April 2016, as listed in
table 1. In addition, FDA is informing the public of the availability,
where applicable, of documentation of environmental review required
under the National Environmental Policy Act (NEPA) and, for actions
requiring review of safety or effectiveness data, summaries of the
basis of approval (FOI Summaries) under the Freedom of Information Act
(FOIA). These public documents may be seen in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to the Internet may obtain these
documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be
accessed in FDA's publication, Approved Animal Drug Products Online
(Green Book), at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

            Table 1--Original and Supplemental NADAs and ANADAs Approved During March and April 2016
----------------------------------------------------------------------------------------------------------------
                                                                           21 CFR
     File No.           Sponsor        Product name         Action        section    FOIA summary   NEPA review
----------------------------------------------------------------------------------------------------------------
141-392..........  Elanco Animal     IMRESTOR          Original           522.1684  yes..........  EA/FONSI \1\
                    Health, a         (pegbovigrastim   approval for
                    Division of Eli   injection).       the reduction
                    Lilly & Co.,                        in the
                    Lilly Corporate                     incidence of
                    Center,                             clinical
                    Indianapolis,                       mastitis in the
                    IN 46285.                           first 30 days
                                                        of lactation in
                                                        periparturient
                                                        dairy cows and
                                                        periparturient
                                                        replacement
                                                        dairy heifers.
141-455..........  Aratana           GALLIPRANT        Original            510.600  yes..........  CE \2\ \3\
                    Therapeutics,     (grapiprant       approval for      520.1084
                    Inc., 11400       tablets).         the control of
                    Tomahawk Creek                      pain and
                    Pkwy., Leawood,                     inflammation
                    KS 66211.                           associated with
                                                        osteoarthritis
                                                        in dogs.
141-460..........  ECO LLC, 344      AIVLOSIN 17%      Original            558.633  yes..........  CE \2\ \4\
                    Nassau St.,       (tylvalosin       approval for
                    Princeton, NJ     tartrate) Type    control of
                    08540.            A Medicated       porcine
                                      Article.          proliferative
                                                        enteropathy
                                                        (PPE)
                                                        associated with
                                                        Lawsonia
                                                        intracellularis
                                                        infection in
                                                        groups of swine
                                                        in buildings
                                                        experiencing an
                                                        outbreak of PPE.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact
  of this action and has made a finding of no significant impact (FONSI).
\2\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an
  environmental assessment or an environmental impact statement because it is of a type that does not have a
  significant effect on the human environment.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(d)(5).

II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee
Mission, KS 66201 (Bayer) has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght,
Dublin 24, Ireland:

----------------------------------------------------------------------------------------------------------------
                   File No.                                       Product name                    21 CFR section
----------------------------------------------------------------------------------------------------------------
099-169.......................................  Oxytocin Injection..............................        522.1680
124-241.......................................  PVL Oxytocin Injectable Solution................        522.1680
200-069.......................................  OvaCyst (gonadorelin diacetate tetrahydrate)            522.1077
                                                 Injection.
200-253.......................................  ProstaMate (dinoprost tromethamine) Injectable           522.690
                                                 Solution.
----------------------------------------------------------------------------------------------------------------

    Bayer has also transferred sponsorship of NADA 141-070 for
RAPINOVET (propofol) Injectable Emulsion to iVaoes Animal Health, 4300
SW 73rd Ave., suite 110, Miami, FL 33155. As provided in the regulatory
text of this document, the animal drug regulations are amended to
reflect these changes of sponsorship.

III. Withdrawals of Approval

    In addition, during March and April 2016, the following two
sponsors have requested that FDA withdraw approval of the NADAs and
ANADAs listed in the following table because the products are no longer
manufactured or marketed:

----------------------------------------------------------------------------------------------------------------
           File No.                       Sponsor                    Product name              21 CFR section
----------------------------------------------------------------------------------------------------------------
007-076 \1\..................  Cross Vetpharm Group Ltd.,    SULFA-NOX Liquid              520.2325a
                                Broomhill Rd., Tallaght,      (sulfaquinoxaline) 3.44%
                                Dublin 24, Ireland.           Solution.
008-244 \1\..................  Cross Vetpharm Group Ltd.,    SULFA-NOX Concentrate         520.2325a
                                Broomhill Rd., Tallaght,      (sulfaquinoxaline) 12.85%
                                Dublin 24, Ireland.           Solution.
041-955 \1\..................  Cross Vetpharm Group Ltd.,    Erythromycin Medicated        558.248
                                Broomhill Rd., Tallaght,      Premix.
                                Dublin 24, Ireland.
049-729 \1\..................  Cross Vetpharm Group Ltd.,    PURINA Sulfa                  520.2261a
                                Broomhill Rd., Tallaght,      (sulfamethazine) 12.5%
                                Dublin 24, Ireland.           Solution.
100-128 \1\..................  Cross Vetpharm Group Ltd.,    Supersweet Medipak TYLAN 10.  558.625
                                Broomhill Rd., Tallaght,
                                Dublin 24, Ireland.
200-307 \1\..................  Vetoquinol N.-A., Inc., 2000  Penicillin G Potassium        520.1696b
                                chemin Georges, Lavaltrie     Soluble Powder.
                                (PQ), Canada J5T 3S5.
----------------------------------------------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for industry #213, ``New Animal Drugs and New
  Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing
  Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,''
  December 2013.

    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 007-076, 008-244, 041-955, 049-729, 100-128, and
ANADA 200-307, and all supplements and amendments thereto, is
withdrawn, effective June 20, 2016. As provided in the regulatory text
of this document, the animal drug regulations are amended to reflect
these voluntary withdrawals of approval.

IV. Technical Amendments

    FDA has noticed that the section heading for 21 CFR 520.1430 does
not accurately reflect the new animal drug for which approved
conditions of use are codified. At this time, we are amending the
section heading to read ``Mibolerone'' rather than ``Megestrol acetate
tablets.'' This action is being taken to improve the accuracy of the
regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520 and 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, parts 510, 520, 522,
556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600:
0
a. In the table in paragraph (c)(1), alphabetically add entries for
``Aratana Therapeutics, Inc.'' and ``iVaoes Animal Health'' and revise
entry for ``Huvepharma AD;'' and
0
b. In the table in paragraph (c)(2), revise the entry for ``016592''
and numerically add entries for ``086026'' and ``086064.''
    The additions and revisions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy.,           086026
 Leawood, KS 66211......................................

                              * * * * * * *
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113          016592
 Sofia, Bulgaria........................................

                              * * * * * * *
iVaoes Animal Health, 4300 SW 73rd Ave., suite 110,               086064
 Miami, FL 33155........................................

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

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
016592......................  Huvepharma EOOD, 5th Floor, 3A Nikolay
                               Haytov Str., 1113 Sofia, Bulgaria

                              * * * * * * *
086026......................  Aratana Therapeutics, Inc., 11400 Tomahawk
                               Creek Pkwy., Leawood, KS 66211

                              * * * * * * *
086064......................  iVaoes Animal Health, 4300 SW 73rd Ave.,
                               suite 110, Miami, FL 33155

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

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
4. Add Sec.  520.1084 to read as follows:

Sec.  520.1084  Grapiprant.

    (a) Specifications. Each tablet contains 20, 60, or 100 milligrams
(mg) grapiprant.
    (b) Sponsor. See No. 086026 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.9 mg/lb (2
mg/kg) once daily by mouth.
    (2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
5. Revise the heading of Sec.  520.1430 to read as follows:

Sec.  520.1430  Mibolerone.

* * * * *

Sec.  520.1696b  [Amended]

0
6. Effective June 20, 2016, in Sec.  520.1696b, in paragraph (b),
remove ``059320,''.

Sec.  520.2261a  [Amended]

0
7. Effective June 20, 2016, in Sec.  520.2261a, in paragraph (b),
remove ``Nos. 016592 and 061623'' and in its place add ``No. 016592''.

Sec.  520.2325a  [Amended]

0
8. Effective June 20, 2016, in Sec.  520.2325a, remove paragraph (a)(2)
and redesignate paragraphs (a)(3) and (4) as paragraphs (a)(2) and (3).

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

    Authority:  21 U.S.C. 360b.

Sec.  522.690  [Amended]

0
10. In Sec.  522.690, in paragraph (b)(3), remove ``000859'' and in its
place add ``061623''.

Sec.  522.1077  [Amended]

0
11. In Sec.  522.1077, in paragraph (b)(3), remove ``000859 and
050604'' and in its place add ``050604 and 061623''.

Sec.  522.1680  [Amended]

0
12. In Sec.  522.1680, in paragraph (b), remove ``000859''.
0
13. Add Sec.  522.1684 to read as follows:

Sec.  522.1684  Pegbovigrastim.

    (a) Specifications. Each pre-filled, single-dose syringe contains
15 milligrams of pegbovigrastim.
    (b) Sponsor. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. Administer the first
dose (syringe) by subcutaneous injection 7 days prior to the cow's or
heifer's anticipated calving date. If necessary, the first dose may be
administered within a range of 4 to 10 days prior to the anticipated
calving date to accommodate management schedules. Administer the second
dose (syringe) by subcutaneous injection within 24 hours after calving.
    (2) Indications for use. For the reduction in the incidence of
clinical mastitis in the first 30 days of lactation in periparturient
dairy cows and periparturient replacement dairy heifers.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  522.2005  [Amended]

0
14. In Sec.  522.2005, in paragraph (b)(1), remove ``000859'' and in
its place add ``086064''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
15. The authority citation for part 556 continues to read as follows:

    Authority:  21 U.S.C. 342, 360b, 371.

0
16. In Sec.  556.748, revise paragraph (c) to read as follows:

Sec.  556.748  Tylvalosin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.2645 and 558.633
of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
17. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
18. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, add
an entry in alphabetical order for ``Tylvalosin'' to read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                        Assay limits percent Type                                Assay limits
                 Drug                               A                Type B maximum (200x)     percent Type B/C
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Tylvalosin............................  90-110...................  3.86 g/lb................             85-115

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

* * * * *

Sec.  558.248  [Amended]

0
19. Effective June 20, 2016, in Sec.  558.248, revise paragraphs (a)
and (b) and remove and reserve paragraph (d)(1)(iii).
    The revisions read as follows:

Sec.  558.248  Erythromycin.

    (a) Specifications. Type A medicated articles containing 5 or 10
percent erythromycin thiocyanate.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  558.625  [Amended]

0
20. Effective June 20, 2016, in Sec.  558.625, remove paragraph (b)(3)
and redesignate paragraphs (b)(4) and (5) as paragraphs (b)(3) and (4).
0
21. Add Sec.  558.633 to read as follows:

Sec.  558.633  Tylvalosin.

    (a) Specifications. Type A medicated articles containing 77.12
grams tylvalosin per pound as tylvalosin tartrate.
    (b) Sponsor. See No. 066916 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.748 of this chapter.
    (d) Special considerations--(1) Federal law restricts tylvalosin
medicated feeds to use under a veterinary feed directive (VFD) and the
professional supervision of a licensed veterinarian. See Sec.  558.6 of
this chapter for additional requirements.
    (2) VFDs for tylvalosin shall not be refilled.
    (3) An expiration date of 1 week is required for tylvalosin Type C
medicated swine feeds in pelleted or crumbled form.
    (e) Conditions of use in swine--(1) Amount. Administer 38.6 grams
tylvalosin per ton of Type C medicated feed (42.5 ppm) as the sole
ration for 14 consecutive days.
    (2) Indications for use. For the control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine in buildings experiencing an outbreak of PPE.

    Dated: May 31, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-13517 Filed 6-7-16; 8:45 am]
 BILLING CODE 4164-01-P