[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4478-4479]
[FR Doc No: 2019-02364]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4414]

Established Conditions; Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency), Center for
Drug Evaluation and Research (CDER) is announcing the opportunity for a
limited number of applicants to participate in an Established
Conditions Pilot Program, to propose explicit established conditions
(ECs) as part of an original new drug application (NDA), abbreviated
new drug application (ANDA), biologics license application (BLA), or as
a prior approval supplement (PAS) to any of these. The concept of ECs
was first described in the FDA draft guidance for industry entitled
``Established Conditions: Reportable CMC Changes for Approved Drug and
Biologic Products'', issued May 2015 and has been further discussed in
the International Council for Harmonisation (ICH) draft guidance for
industry entitled ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management; International Council for
Harmonisation'', issued May 30, 2018. FDA is implementing this pilot
program to gain experience receiving, assessing, and engaging with
applicants regarding proposed ECs (i.e., explicit ECs).

DATES: FDA will accept nine requests submitted before May 30, 2019 from
applicants intending to submit NDAs, ANDAs, or BLAs, either original
applications or prior approval supplements, with proposed ECs.

FOR FURTHER INFORMATION CONTACT: Ashley Boam, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Silver Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The concept of ECs was first described in the FDA draft guidance
for industry entitled ``Established Conditions: Reportable CMC Changes
for Approved Drug and Biologic Products'' (hereafter, ``FDA guidance'')
issued May 2015 (80 FR 31050) and has been further discussed in the ICH
draft guidance for industry entitled ``Q12 Technical and Regulatory
Considerations for Pharmaceutical Product Lifecycle Management;
International Council for Harmonisation'', (hereafter ``ICH Q12
guidance'') issued May 30, 2018 (83 FR 25018).
    The regulations at Sec. Sec.  314.50(d)(1), 314.54(a)(1), and
314.94(a)(9) (21 CFR 314.50(d)(1), 314.54(a)(1), and 314.94(a)(9))
require that any NDA or ANDA submitted to the Agency contain a
chemistry, manufacturing, and controls (CMC) section that describes
information such as the composition of the drug product, manufacture of
the drug substance, and manufacture of the drug product. Similarly,
under Sec.  601.2 (21 CFR 601.2), applicants submitting BLAs must also
provide relevant CMC information, such as a full description of
manufacturing methods and data establishing stability of the product
through the dating period.
    All changes after approval of an application must be managed and
executed in conformance with current good manufacturing practice
(CGMP), although Sec. Sec.  314.70(a) and 601.12(a) only require a
subset of changes to be reported to the FDA. Sections 314.70(a)(1)(i)
and 314.97 require that, other than the exceptions or alternatives
provided in Sec.  314.70(a)(1)(ii), an applicant notify FDA about each
change in each condition established in an approved NDA or ANDA beyond
the variations already provided for in the approved application. Per
Sec.  601.12(a)(1), an applicant must inform FDA about each change in
the product, production process, quality controls, equipment,
facilities, responsible personnel, or labeling established in the
approved BLA.
    After approval of an application, applicants desiring to make
changes to this CMC information must evaluate the changes in the
context of the regulations to determine if there is a need to report
the change and associated supporting data and justifications to FDA.
Although the reporting mechanism for many CMC changes has been made
clear through publication of various guidance documents, FDA issued its
draft guidance on ECs due to concern that there is confusion regarding
which elements of an application are considered to be ECs. This
confusion could have a negative impact on change management activities
and could discourage continual improvement in product manufacturing
processes, lead to unnecessary submission of postapproval supplements
to FDA for changes that could be managed solely by a manufacturer's
Pharmaceutical Quality System, or, upon inspection, lead to Form FDA
483 observations for changes that should have been reported to FDA.
Moreover, a better understanding of which elements of the CMC
information constitute ECs to FDA, and where in an application these
elements are generally expected to be described, could allow for a more
effective postapproval submission strategy (e.g., effective use of risk
management principles in ICH Q9 ``Quality Risk Management,'' and
knowledge management as defined in ICH Q10 ``Pharmaceutical Quality
System'') by the regulated industry.
    In the FDA draft guidance, ECs are defined as the description of
the product, manufacturing process, facilities and equipment, and
elements of the associated control strategy, as defined in an
application, that assure process performance and quality of an approved
product. Changes to the ECs must be reported to FDA (Sec. Sec.  314.70
and 601.12). This definition is consistent with the ICH Q12 guidance,
which states that ``ECs are legally binding information (or approved
matters) considered necessary to assure product quality. Consequently,
any change to ECs necessitates a submission to the regulatory
authority.''
    Although each application submitted to the Agency contains ECs, as
described in Sec. Sec.  314.70(a) and 601.12(a), FDA has not
specifically indicated the applicable ECs for each application at the
time of approval. In addition, the draft ICH Q12 guidance describes how
an applicant can specifically identify and propose so-called
``explicit'' ECs in which the EC itself or the reporting category for
the EC, if changed, differs from existing requirements as described in
regulations and guidance. Such explicit ECs should be supported by an
appropriate justification that takes into consideration the applicant's
development approach and risk to product quality. FDA recognizes that
this process will be new for both applicants and Agency staff.
Therefore, FDA is proposing this pilot program.

II. Objectives

    The objectives of this pilot program are to gain practical
experience in:
     Assessing proposed ECs (i.e., explicit ECs);
     engaging with applicants during the review cycle to refine
proposed ECs;
     ensuring assessment decisions are made without negatively
impacting the ability to meet user fee timeframes; and
     identifying agreed-upon ECs at the time of approval.
    FDA further encourages applicants who are accepted into this pilot
program to pursue pre-submission meetings (pre-NDA, pre-BLA, or pre-
ANDA, where

appropriate) through existing mechanisms. See, for example, FDA draft
guidances entitled ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products and Formal Meetings Between the FDA and
Sponsors or Applicants of BsUFA Products'' (once final, these guidance
documents will represent FDA's current thinking on these topics) to
improve the likelihood that a list of agreed-upon ECs can be reached
prior to application approval. Although FDA's Center for Biologics
Evaluation and Research (CBER) is not participating in this pilot, CBER
intends to leverage CDER's experience from the pilot as CBER assesses
explicit ECs in future submissions.

III. Requests To Participate

    Parties who have an interest in participating in this Established
Conditions Pilot Program and who plan to propose explicit ECs in an
upcoming marketing application should submit a written request to the
<EMAIL_ADDRESS>mailbox. The request should specify the
request to participate in the Established Conditions Pilot Program.
    The request should also include the following items:
    1. The contact person's name, company name, and company contact
information.
    2. The proposed application type (NDA, ANDA, BLA; original or
supplement).
    3. The established name of the proposed product and a brief
description (e.g., dosage form, indication).
    4. Plans for any pre-NDA, pre-BLA, or pre-ANDA meetings to take
place prior to application submission. Requests for such meetings
should follow previously established procedures as outlined in relevant
guidance documents.
    5. Expected timing for submission of the application. The
submission should be planned for receipt by FDA no later than July 1,
2019.
    6. Acknowledgement that participation in the pilot program may be
discontinued if the manufacturing facilities named in the application
are not in a state of compliance with CGMP at the time of the
application submission.
    We intend to accept nine requests that meet the criteria above and
represent a variety of application types, as Agency resources allow.
FDA expects to notify companies of its decision regarding acceptance
into the pilot program in writing within 60 days of receipt of the
request. Although incomplete and/or unclear requests will generally be
denied, FDA may contact the applicant to request additional
information.
    FDA intends to accept requests to participate starting on the date
of publication of this notice.

IV. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
    The collections of information in 21 CFR part 314 for submitting
NDAs and ANDAs have been approved under OMB control number 0910-0001,
and the collections of information in 21 CFR part 601 for submitting
BLAs has been approved under OMB control number 0910-0338.
    FDA also has OMB approval under control number 0910-0429 for
submissions under the guidance for industry entitled ``Formal Meetings
Between the FDA and Sponsors or Applicants,'' and under the guidance
for industry ``Controlled Correspondence Related to Generic Drug
Development'' (OMB control number 0910-0797).

V. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are
also available electronically at https://www.regulations.gov. FDA
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. FDA draft guidance for industry entitled ``Established
Conditions: Reportable CMC Changes for Approved Drug and Biologic
Products'' (May 2015), available at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm448638.pdf.
2. FDA draft guidance for industry entitled ``ICH Q12 Technical and
Regulatory Considerations for Pharmaceutical Product Lifecycle
Management'' (May 2018), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609205.pdf.
3. FDA draft guidance for industry entitled ``Formal Meetings
Between the FDA and Sponsors or Applicants for PDUFA Products''
(December 2017), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf.
4. FDA draft guidance for industry entitled ``Formal Meetings
Between the FDA and Sponsors or Applicants of BsUFA Products'' (June
2018), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609662.pdf.
5. FDA draft guidance for industry entitled ``Controlled
Correspondence Related to Generic Drug Development'' (November
2017), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM583436.pdf.

    Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02364 Filed 2-14-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 70 (Friday, April 10, 2020)]
[Notices]
[Pages 20263-20264]
[FR Doc No: 2020-07580]

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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: ER20-1495-000.
    Applicants: Bucksport Generation LLC.
    Description: Sec.  205(d) Rate Filing: Normal filing 2020 to be
effective 4/4/2020.
    Filed Date: 4/3/20.
    Accession Number: 20200403-5147.
    Comments Due: 5 p.m. ET 4/24/20.

    Docket Numbers: ER20-1496-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA, Service
Agreement No. 5522; Queue No. AE1-075 to be effective 10/14/2019.
    Filed Date: 4/3/20.
    Accession Number: 20200403-5160.
    Comments Due: 5 p.m. ET 4/24/20.

    Docket Numbers: ER20-1497-000.
    Applicants: ISO New England Inc.
    Description: Sec.  205(d) Rate Filing: ISO-NE Ministerial Filing to
Conform Section III.13.6 of the Tariff to be effective 6/1/2020.
    Filed Date: 4/3/20.
    Accession Number: 20200403-5182.
    Comments Due: 5 p.m. ET 4/24/20.

    Docket Numbers: ER20-1498-000.
    Applicants: Krayn Wind LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff of
Krayn Wind, LLC.
    Filed Date: 4/3/20.
    Accession Number: 20200403-5194.
    Comments Due: 5 p.m. ET 4/24/20.

    Docket Numbers: ER20-1499-000.
    Applicants: Appalachian Power Company.
    Description: Sec.  205(d) Rate Filing: OATT--AEP Texas Inc. 1-Co
Rate Update, Attach K and Misc related revisions to be effective 12/31/
9998.
    Filed Date: 4/3/20.
    Accession Number: 20200403-5198.
    Comments Due: 5 p.m. ET 4/24/20.

    Docket Numbers: ER20-1500-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2020-04-06_SA 3471 Entergy
Mississippi-Steelhead Wind 2 GIA (J866) to be effective 3/23/2020.
    Filed Date: 4/6/20.
    Accession Number: 20200406-5008.
    Comments Due: 5 p.m. ET 4/27/20.

    Docket Numbers: ER20-1501-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2020-04-06_Quarterly Tariff
Clean-up Filing to be effective 4/7/2020.
    Filed Date: 4/6/20.
    Accession Number: 20200406-5024.
    Comments Due: 5 p.m. ET 4/27/20.

    Docket Numbers: ER20-1502-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Sec.  205(d) Rate Filing: New Wholesale Power Supply
Contract--Parke Co REMC to be effective 6/5/2020.
    Filed Date: 4/6/20.
    Accession Number: 20200406-5077.
    Comments Due: 5 p.m. ET 4/27/20.

    Docket Numbers: ER20-1503-000.
    Applicants: North Star Solar, LLC.
    Description: Baseline eTariff Filing: NSS-Little Bear Shared Gen-
Tie Facilities Common Ownership Agreement Filing to be effective 4/7/
2020.
    Filed Date: 4/6/20.
    Accession Number: 20200406-5151.
    Comments Due: 5 p.m. ET 4/27/20.

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

    Docket Numbers: ES20-17-000.
    Applicants: Trans Bay Cable LLC.
    Description: Supplement to February 21, 2020 Application Under
Section 204 of the Federal Power Act for Authorization to Issue
Securities of Trans Bay Cable LLC.
    Filed Date: 4/3/20.
    Accession Number: 20200403-5228.
    Comments Due: 5 p.m. ET 4/10/20.

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

docs-filing/efiling/filing-req.pdf. For other information, call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 6, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-07580 Filed 4-9-20; 8:45 am]
 BILLING CODE 6717-01-P


FLUMETSULAM 129016

Screening Level Usage Analysis (SLUA)

Date: November 19, 2007

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active
ingredient that is used on agricultural crops in the United States.

Pesticide usage data obtained from various sources.  The data are then
merged, averaged, and rounded so that the presented information is not
proprietary, business confidential, or trade secret.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used
on.

Available pesticide usage information from U.S. states that produce 80%
or more of a crop, in most cases, or less than 80%, in rare cases,
depending on the scope of the survey and available resources.

Annual percent of crop treated (average & maximum) for each agricultural
crop.

Average annual pounds of the pesticide applied for each agricultural
crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by
merging pesticide usage data sources together; averaging across all
observations, then rounding.  Note:  If the estimated value is less than
500, then that value is labeled <500.  Estimated values between 500 &
<1,000,000 are rounded to 1 significant digit.  Estimated values of
1,000,000 or greater are rounded to 2 significant digits.)

Average percent of crop treated - Values are calculated by merging data
sources together; averaging by year, averaging across all years, &
rounding to the nearest multiple of 5.  Note:  If the estimated value is
less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value
reported across all data sources, across all years, & rounded up to the
nearest multiple of 5.  Note:  If the estimated value is less than 2.5,
then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National
Agricultural Statistics Service) – pesticide usage data from 2001 to
2006.

Private pesticide market research – pesticide usage data from 2001 to
2006.

NPUD 2002 (National Pesticide Use Database) pesticide usage data from
NPUD 02 of the CropLife Foundation are used only if data are not
available from the other sources.

California Department of Pesticide Regulation (DPR) Pesticide Use
Reporting (PUR) data for 2000 to 2005 when 95% or more of a crop is
grown California.

What are the limitations to the data?

Additional registered uses may exist but are not included because the
available surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply
zero usage.

Usage data on a particular site may be noted in data sources, but not
quantified.  In these instances, the site would not be reported in the
SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control,
etc.) are not reported in the SLUA.  A separate request must be made to
receive these estimates.

Some sites show some use, even though they are not on the label.  This
usage could be due to various factors, including, but not limited to
Section 18 requests, existing stocks of the chemical, data collection
errors, and experimental use permits (EUPs).

November 19, 2007

Screening Level Estimates of Agricultural Uses of  FLUMETSULAM 129016

Sorted Alphabetically

		Crop				Lbs. A. I.			Percent Crop Ttd.

	  	 								Avg.	      Max.

	1 	Celery +	<500	<1           <2.5

	2 	Corn	200,000	10             10

	3 	Fallow, Summer +	<500	<1           <2.5

	4 	Soybeans	20,000	<1           <2.5

	5 	Sunflowers +	<500	<1           <2.5

	6 	Sweet Corn +	<500	<1           <2.5

All numbers rounded.

'<500' indicates less than 500 pounds of active ingredient.

'<2.5' indicates less than 2.5 percent of crop is treated.

'<1' indicates less than 1 percent of crop is treated.

SLUA data sources include:

	USDA-NASS (United States Department of Agriculture's National
Agricultural Statistics Service);

            2001-2006

	Private Pesticide Market Research,2001-2006

	NPUD 2002 (National Pesticide Use Database) of the CropLife America
Foundation and California

            DPR data.

	These results reflect amalgamated data developed by the Agency and are
releasable to the public.

+ = These crops were not listed as active product registrations when
this report was run.


[Federal Register Volume 82, Number 146 (Tuesday, August 1, 2017)]
[Rules and Regulations]
[Pages 35628-35630]
[FR Doc No: 2017-15477]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0330; Directorate Identifier 2017-NM-016-AD;
Amendment 39-18972; AD 2017-15-12]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 737-300, -400, and -500 series airplanes. This
AD was prompted by an evaluation by the design approval holder (DAH)
indicating that the lower skin at the skin lap splice lower fastener
row is subject to widespread fatigue damage (WFD). This AD requires
repetitive inspections for cracking in the skin lap splice at the lower
fastener row, and repair if necessary. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective September 5, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September 5,
2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110 SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. Boeing Alert Service Bulletin 737-53A1365,
dated January 23, 2017, is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0330.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0330; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the regulatory evaluation, any comments
received, and other information. The address for the Docket Office
(phone:<PHONE_NUMBER>) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: James Guo, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5357; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 737-300, -400, and -500 series airplanes. The NPRM published in
the

Federal Register on May 1, 2017 (82 FR 20288). The NPRM was prompted by
an evaluation by the DAH indicating that the lower skin at the skin lap
splice lower fastener row is subject to WFD. The NPRM proposed to
require repetitive inspections for cracking in the skin lap splice at
the lower fastener row, and repair if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Supportive Comment

    Boeing stated that it concurred with the NPRM.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing the supplemental
type certificate (STC) ST01219SE does not affect the actions specified
in the NPRM.
    We concur with the request. We have redesignated paragraph (c) of
the proposed AD as paragraph (c)(1) of this AD and added paragraph
(c)(2) to this AD to state that installation of STC ST01219SE does not
affect the ability to accomplish the actions required by this AD.
Therefore, for airplanes on which STC ST01219SE is installed, a
``change in product'' alternative method of compliance (AMOC) approval
request is not necessary to comply with the requirements of 14 CFR
39.17.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule with the change described previously and minor
editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1365, dated
January 23, 2017. The service information describes procedures for eddy
current inspections for cracking at the skin lap splice in the lower
fastener row, and repair if necessary. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 126 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
           Action                  Labor cost         Parts cost       Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspection.................  84 work-hours x $85                $0  $7,140 per inspection  $899,640 per
                              per hour = $7,140                      cycle.                 inspection cycle.
                              per inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-15-12 The Boeing Company: Amendment 39-18972; Docket No. FAA-
2017-0330; Directorate Identifier 2017-NM-016-AD.

(a) Effective Date

    This AD is effective September 5, 2017.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to The Boeing Company Model 737-300, -400,
and -500 series airplanes, certificated in any category,

as identified in Boeing Alert Service Bulletin 737-53A1365, dated
January 23, 2017.
    (2) Installation of Supplemental Type Certificate (STC)
ST01219SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/EBD1CEC7B301293E86257CB30045557A?OpenDocument&Highlight=st01219se)
does not affect the ability to accomplish the actions required by
this AD. Therefore, for airplanes on which STC ST01219SE is
installed, a ``change in product'' alternative method of compliance
(AMOC) approval request is not necessary to comply with the
requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53; Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder indicating that the lower skin at the skin lap splice lower
fastener row is subject to widespread fatigue damage. We are issuing
this AD to detect and correct cracks in the lower skin, which, if
not detected, could link up, resulting in reduced structural
integrity of the airplane and consequent uncontrolled decompression
of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    Except as provided by paragraph (i) of this AD, at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1365, dated January 23, 2017:
Do external eddy current inspections at stringer S-14 on the left
and right sides of the airplane (S-14L and S-14R) for any crack in
the skin lap splice at the lower fastener row, in accordance with
the Accomplishment Instructions of Boeing Alert Service Bulletin
737-53A1365, dated January 23, 2017. Repeat the inspections
thereafter at the applicable times specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1365, dated
January 23, 2017.

(h) Repair

    If any crack is found during any inspection required by
paragraph (g) of this AD, repair before further flight using a
method approved in accordance with the procedures specified in
paragraph (j) of this AD. Although Boeing Alert Service Bulletin
737-53A1365, dated January 23, 2017, specifies to contact Boeing for
appropriate action and specifies that action as ``RC'' (Required for
Compliance), this AD requires repair as specified in this paragraph.

(i) Exceptions to Service Information Specifications

    (1) Where Boeing Alert Service Bulletin 737-53A1365, dated
January 23, 2017, specifies a compliance time ``after the original
issue date of this service bulletin,'' this AD requires compliance
within the specified compliance time after the effective date of
this AD.
    (2) The Condition column of Table 1 and Table 2 of paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-53A1365,
dated January 23, 2017, refers to total flight cycles ``at the
original issue date of this service bulletin.'' This AD, however,
applies to the airplanes with the specified total flight cycles as
of the effective date of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) Except as required by paragraph (h) of this AD: For service
information that contains steps that are labeled as Required for
Compliance (RC), the provisions of paragraphs (j)(4)(i) and
(j)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    For more information about this AD, contact James Guo, Aerospace
Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960
Paramount Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 737-53A1365, dated January 23,
2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 14, 2017.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-15477 Filed 7-31-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Notices]
[Page 32912-32913]
[DOCID:fr09jy09-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD09-8-000]

Transmission Planning Processes Under Order No. 890; Notice of
Technical Conferences

June 30, 2009.
    Take notice that Commission staff will convene technical
conferences on the following dates in the following cities to examine
the planning processes that are being conducted pursuant to Order No.
890.\1\ Staff expects all transmission providers to participate in the
technical conference for their particular region, although all
interested persons, including transmission providers in other regions,
regional representatives, transmission customers, developers of
merchant transmission and distributed generation, and other resource
developers are also invited to participate in each conference.
---------------------------------------------------------------------------

    \1\ Preventing Undue Discrimination and Preference in
Transmission Service, Order No. 890, FERC Stats. & Regs. ] 31,241,
order on reh'g, Order No. 890-A, FERC Stats. & Regs. ] 31,261
(2007), order on reh'g, Order No. 890-B, 123 FERC ] 61,299, (2008)
order on reh'g, Order No. 890-C, 126 FERC ] 61,228 (2009).
---------------------------------------------------------------------------

    In Order No. 890, the Commission directed all transmission
providers to develop a transmission planning process that satisfies
nine principles and to clearly describe that process in a new
attachment to their open access transmission tariffs.\2\ On December 7,
2007, pursuant to Order No. 890, most public utility transmission
providers and several non-public utility transmission owners submitted
their proposed transmission planning processes.\3\ The Commission
subsequently addressed these filings in a series of orders that were
issued throughout 2008. Generally, the Commission accepted each of the
transmission planning processes to be effective December 7, 2007,
subject to further compliance filings required to meet the nine
planning principles (Initial Planning Orders). The Commission also
noted that its staff would periodically monitor the implementation of
these processes, and it stated its intent to convene regional technical
conferences in 2009 to assess them.
---------------------------------------------------------------------------

    \2\ Order No. 890, FERC Stats. & Regs. ] 31,241 at P 418-602.
    \3\ A small number of transmission providers were granted
extensions.
---------------------------------------------------------------------------

    Recently, the Commission issued a series of orders addressing the
further transmission planning process compliance filings (Compliance
Filing Orders). In each of the Compliance Filing Orders, the Commission
emphasized that it remains interested in the development of
transmission planning processes and will continue to examine the
adequacy of the processes accepted to date. The Commission reiterated
the encouragement made in prior orders for further refinements and
improvements to the planning processes as transmission providers, their
customers, and other stakeholders gain more experience through actual
implementation of the processes. The Commission also re-stated that, as
part of its ongoing evaluation of the implementation of the planning
processes, it intended to convene regional technical conferences this
year to determine if further refinements to these processes are
necessary.
    The conferences scheduled in this notice are intended to meet the
Commission's commitment made in the Initial Planning Orders and
Compliance Filing Orders that its staff would conduct an assessment of
the Order No. 890 transmission planning processes. Consistent with
these orders, the focus of the 2009 regional technical conferences will
be: (1) To determine the progress and benefits realized by each
transmission provider's transmission planning process, obtain customer
and other stakeholder input, and discuss any areas that may need
improvement; (2) to examine whether existing transmission planning
processes adequately consider needs and solutions on a regional or
interconnection-wide basis to ensure adequate and reliable supplies at
just and reasonable rates; and (3) to explore whether existing
processes are sufficient to meet emerging challenges to the
transmission system, such as the development of interregional
transmission facilities, the integration of large amounts of location-
constrained generation, and the interconnection of distributed energy
resources.
---------------------------------------------------------------------------

    \4\ Staff also requests that a representative of WECC's
Transmission Expansion Planning Policy Committee attend this
technical conference.

------------------------------------------------------------------------
                                                   Transmission provider
             Date                    Location           participants
------------------------------------------------------------------------
September 3, 2009.............  Phoenix Airport    Entities located
                                 Marriott, 1101     within the
                                 North 44th         ColumbiaGrid,
                                 Street, Phoenix,   Northern Tier
                                 AZ 85008.          Transmission Group,
                                                    WestConnect, and
                                                    CAISO footprints,
                                                    and other entities
                                                    in the WECC region
                                                    that are not a part
                                                    of any of these
                                                    subregional
                                                    groups.\4\
                                                   Those wishing to
                                                    participate as a
                                                    panelist and provide
                                                    feedback on the
                                                    planning issues
                                                    described above
                                                    should submit a
                                                    request form by
                                                    close of business on
                                                    August 13, 2009,
                                                    located at: https://
                                                    www.ferc.gov/
                                                    whatsnew/
                                                    registration/
                                                    trans0903speakerform
                                                    .asp.
September 10, 2009............  Sheraton Gateway   Entities located in
                                 Hotel Atlanta      the states
                                 Airport, 1900      represented in the
                                 Sullivan Road,     Southeastern
                                 Atlanta, GA        Association of
                                 30337.             Regulatory Utility
                                                    Commissioners and
                                                    entities located in
                                                    the Southwest Power
                                                    Pool footprint.
                                                   Those wishing to
                                                    participate as a
                                                    panelist and provide
                                                    feedback on the
                                                    planning issues
                                                    described above
                                                    should submit a
                                                    request form by
                                                    close of business on
                                                    August 20, 2009
                                                    located at: https://
                                                    www.ferc.gov/
                                                    whatsnew/
                                                    registration/
                                                    trans0910speakerform
                                                    .asp
September 21, 2009............  Marriott           Entities located
                                 Philadelphia       within the Midwest
                                 Airport, One       ISO, PJM, New York
                                 Arrivals Road,     ISO, and ISO New
                                 Philadelphia, PA   England footprints,
                                 19153.             MAPP/MAPP
                                                    Participants, and
                                                    adjacent areas.

                                                   Those wishing to
                                                    participate as a
                                                    panelist and provide
                                                    feedback on the
                                                    planning issues
                                                    described above
                                                    should submit a
                                                    request form by
                                                    close of business on
                                                    August 31, 2009,
                                                    located at: https://
                                                    www.ferc.gov/whats-
                                                    new/registration/
                                                    trans 09 21 speaker
                                                    form.asp.
------------------------------------------------------------------------

    A further notice with a detailed agenda for each conference will be
issued in advance of the conferences. In the event a transmission
provider is uncertain as to which technical conference is the
appropriate forum for discussion of its planning process, such
transmission providers should contact Commission staff in advance to
discuss the matter. Lastly, a comment date will be set at a later date
allowing for the filing of post-conference comments.
    For further information about these conferences, please contact:

Zeny Magos (Technical Information), Office of Energy Markets and
Reliability, Federal Energy Regulatory Commission, 888 First Street,
NE., Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>John Cohen (Legal Information), Office of the General Counsel--Energy
Markets, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E9-16170 Filed 7-8-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 85 (Friday, May 1, 2020)]
[Notices]
[Pages 25431-25432]
[FR Doc No: 2020-09319]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2513-090]

Green Mountain Power Corporation; Notice of Intent To File
License Application, Filing of Pre-Application Document (PAD),
Commencement of Pre-Filing Process, and Scoping; Waiving Parts of the
Pre-Filing Process; Request for Comments on the Pad and Scoping
Document, and Identification of Issues and Associated Study Requests

    a. Type of Filing: Notice of Intent to File License Application for
a New

License and Commencing Pre-filing Process.
    b. Project No.: 2513-090.
    c. Dated Filed: February 27, 2020.
    d. Submitted By: Green Mountain Power Corporation.
    e. Name of Project: Essex No. 19 Hydroelectric Project.
    f. Location: On the Winooski River, in Chittenden County, Vermont.
The project does not occupy federal lands.
    g. Filed Pursuant to: 18 CFR part 5 of the Commission's
Regulations.
    h. Licensee Contact: Mr. John Greenan, Green Mountain Power
Corporation, 1252 Post Road, Rutland, Vermont 05701; phone: (802) 770-
2195 or email at John.Greenan@greenmountainpower.com;.
    i. FERC Contact: Michael Tust at<PHONE_NUMBER> or email at
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item o below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC ]
61,076 (2001).
    k. With this notice, we are initiating informal consultation with:
(a) the U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402 and (b) the State Historic
Preservation Officer, as required by section 106, National Historic
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Green Mountain Power
Corporation (Green Mountain Power) as the Commission's non-federal
representatives for carrying out informal consultation, pursuant to
section 7 of the Endangered Species Act and section 106 of the National
Historic Preservation Act.
    m. Green Mountain Power filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents via the internet through
the Commission's Home Page (http://www.ferc.gov) using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. With this notice, we are soliciting comments on the PAD and
Commission's staff Scoping Document 1 (SD1), as well as study requests.
All comments on the PAD and SD1, and study requests should be sent to
the address above in paragraph h. In addition, all comments on the PAD
and SD1, study requests, requests for cooperating agency status, and
all communications to and from Commission staff related to the merits
of the potential application must be filed with the Commission.
    The Commission strongly encourages electronic filing. Please file
all documents using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
[email protected]
    All filings with the Commission must bear the appropriate heading:
``Comments on Pre-Application Document,'' ``Study Requests,''
``Comments on Scoping Document 1,'' ``Request for Cooperating Agency
Status,'' or ``Communications to and from Commission Staff.'' Any
individual or entity interested in submitting study requests,
commenting on the PAD or SD1, and any agency requesting cooperating
status must do so by June 26, 2020.
    p. Although our current intent is to prepare an environmental
assessment (EA), there is the possibility that an Environmental Impact
Statement (EIS) will be required. Nevertheless, this scoping document
will satisfy the NEPA scoping requirements, irrespective of whether an
EA or EIS is issued by the Commission.

Scoping Meetings and Environmental Site Review

    Due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020, we are waiving section 5.8(b)(viii) of the Commission's
regulations and do not intend to conduct a public scoping meeting or
site visit in this case. Instead, we are soliciting written comments,
recommendations, and information, on the SD1. Any individual or entity
interested in submitting scoping comments must do so by the date
specified in item o. SD1, which outlines the subject areas to be
addressed in the environmental document, was mailed to the individuals
and entities on the Commission's mailing list. Copies of SD1 may be
viewed on the web at http://www.ferc.gov, using the ``eLibrary'' link.
Follow the directions for accessing information in paragraph n. Based
on all written comments, a Scoping Document 2 (SD2) may be issued. SD2
may include a revised process plan and schedule, as well as a list of
issues, identified through the scoping process.
    We may conduct the site visit, if needed, later in the process,
such as in conjunction with the study plan meeting required by section
5.11(e) of the Commission's regulations which is required to occur by
September 9. 2020. Further revisions to the schedule may be made as
appropriate.

    Dated: April 27, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-09319 Filed 4-30-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 20, 2008 (Volume 73, Number 225)]
[Notices]
[Page 70343-70344]
[DOCID:fr20no08-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1881-050]

PPL Holtwood, LLC, Pennsylvania; Notice of Availability of the
Final Environmental Impact Statement for the Holtwood Project

November 14, 2008.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the capacity related amendment
application for PPL Holtwood LLC's 107.2-megawatt Holtwood
Hydroelectric Project (Project No. 1881), located on the Susquehanna
River in the counties of Lancaster and York, Pennsylvania. Based upon
this review, the Office of Energy Projects has prepared a Final
Environmental Impact Statement (final EIS) for the project.
    The final EIS contains staff's evaluation of the applicant's
proposal and alternatives. The proposal is for the construction of a
new powerhouse, installation of turbines, construction of a new skimmer
wall, enlargement of the forebay, and reconfiguration of the project
facilities to enhance upstream fish passage through modifications of
the existing fishway and excavation in the tailrace channel. The
installed capacity would increase by approximately 80 MW. Additionally,
PPL Holtwood LLC requested a 16-year extension of the current license
term until August 31, 2030. The final EIS documents the views of
governmental agencies, non-governmental organizations, affected Indian
tribes, the public, and Commission staff.
    A copy of the final EIS is available for review in the Commission's
Public Reference Branch, Room 2A, located at 888 First Street, NE.,
Washington, DC 20426. The final EIS also may be viewed on the
Commission's Web site at http://www.ferc.gov under the eLibrary link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-
3676, or for TTY,<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects.

For assistance, contact FERC Online Support.
    For Further Information Contact: Blake Condo at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E8-27565 Filed 11-19-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 2, 2009 (Volume 74, Number 230)]
[Rules and Regulations]
[Page 63066-63069]
[DOCID:fr02de09-3]

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

40 CFR Part 52

[EPA-R05-OAR-2007-1130; FRL-9087-7]

Approval and Promulgation of Air Quality Implementation Plans;
Minnesota

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is approving a site-specific revision to the Minnesota
sulfur dioxide (SO2) State Implementation Plan (SIP) for the
Rochester Public Utilities Silver Lake Plant (RPU-SLP), located in
Rochester, Minnesota. In its October 16, 2007, submittal, the Minnesota
Pollution Control Agency (MPCA) requested that EPA approve certain
conditions contained in RPU-SLP's revised Federally enforceable joint
Title I/Title V document into the Minnesota SO2 SIP. The
request is approvable because it satisfies the requirements of the
Clean Air Act (CAA). The rationale for the approval and other
information are provided in this rulemaking action.

DATES: This direct final rule will be effective February 1, 2010,
unless EPA receives adverse comments by January 4, 2010. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2007-1130, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: John M. Mooney, Chief, Criteria Pollutant Section, Air
Programs Branch (AR 18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: John M. Mooney, Chief, Criteria Pollutant
Section, Air Programs Branch (AR 18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2007-1130. 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 http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
www.regulations.gov your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your

name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This Facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. We recommend that you telephone Christos Panos, Environmental
Engineer, at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Christos Panos, Environmental
Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. General Information
    1. What Is the Background for This Action?
    2. Why Is EPA Taking This Action?
    3. What Is a ``Title I Condition?''
II. What Action Is EPA Taking?
III. Statutory and Executive Order Reviews

I. General Information

1. What Is the Background for This Action?

    The Silver Lake Plant is an electric generating station located at
425 West Silver Lake Drive Northeast, in Rochester, Olmsted County,
Minnesota, having a total generating capacity of approximately 100
megawatts. Emission sources at the facility include four pulverized
coal-fired dry-bottom boilers, a natural-gas-fired steam heating
boiler, coal handling and storage facilities, fly and bottom ash
storage and handling facilities, and fugitive emissions from unpaved
roads. Boilers 1, 2, 3, and 4 were constructed in 1949, 1952, 1962, and
1969, respectively. The primary fuels for these four boilers are
bituminous coal and natural gas.
    Emission limits for the four boilers were part of the 1981
Rochester SO2 SIP approved by EPA. On March 9, 2001 (66 FR
14087), EPA approved a Title V permit into the SIP entitled ``Minnesota
Air Emission Permit No. 10900011-001,'' issued to RPU-SLP on July 22,
1997. This Title V permit included 24-hour average Total Ambient
Culpability Weighted Emission Factor (TACWEF) equations that limited
the facility to 2718.6 pounds per hour (lbs/hr) of SO2, to
provide for attainment and maintenance of the SO2 National
Ambient Air Quality Standards (NAAQS). Other SO2 SIP
requirements were included in the Title V permit for operation of
Continuous Emission Monitors (CEMs), recordkeeping, and reporting
deviations.
    The Title V permit also contained emission limits and control
strategies for particulate matter (PM) with an aerodynamic diameter
less than or equal to a nominal 10 micrometers (PM10). These emission
limits and control strategies were originally contained in an
administrative order for RPU-SLP previously approved by EPA as part of
the Rochester PM10 SIP on June 13, 1995 (60 FR 31088). EPA
inadvertently omitted incorporating by reference the PM10 limits when
the Title V permit replaced the administrative orders in Minnesota's
SIP on March 9, 2001. These PM10 limits still apply to the facility and
are included in the joint Title I/Title V document as Title I SIP
conditions.
    The SIP revision submitted by MPCA on October 16, 2007, consists of
``Minnesota Air Emission Permit No. 10900011-004,'' issued to RPU-SLP
on September 7, 2007, which serves as a joint Title I/Title V document.
The State has requested that EPA approve into the Minnesota
SO2 SIP only the portions of the permit cited as ``Title I
Condition: State Implementation Plan for SO2'' and ``Title I
Condition: State Implementation Plan for PM10.''
    Minnesota held a public hearing regarding the SIP revision and the
joint Title I/Title V document on August 23, 2007. The MPCA received
one public comment in support of the Title V permit and SIP revision.

2. Why Is EPA Taking This Action?

    EPA is taking this action because the State's SIP submittal for
RPU-SLP is fully approvable. The SIP revision results in a substantial
decrease in SO2 emissions and satisfies the applicable
SO2 requirements of the CAA.
    Under the 2001 SIP conditions, the four boilers are limited to a
3.2 lb/mmBtu emission limit for SO2 when operating alone,
and to sulfur emission limits determined based on TACWEF equations when
more than one unit is operating on coal at the same time. The
facility's SIP approved PM10 limits are carried over into the joint
Title I/Title V document and have not changed in content since they
were approved by EPA in 1995.
    RPU-SLP initiated changes to the facility to comply with the Clean
Air Interstate Rule (CAIR) and to meet their Best Available Retrofit
Technology (BART) obligations under the Regional Haze Rule. The changes
also satisfy the terms of a 2006 settlement agreement between the
Minnesota Center for Environmental Advocacy (MCEA), MPCA, and RPU-SLP,
which resulted from MCEA's appeal of a previous permit amendment to
RPU-SLP, ``Air Emissions Permit No. 10900011-003'' issued in 2004.
Significant changes that occurred in that permit action included a
decreased limit on the amount of coal burned per year and lower
SO2 emission limits. A SIP revision was not required for the
2004 permit amendment because the SO2 limits in that permit
satisfied the SO2 limits in the SIP. In order to meet the
requirements of the settlement, RPU-SLP initiated a project to install
additional pollution control equipment for SO2, PM, and
Nitrogen Oxides (NOx) on Unit 4. A spray-dryer absorber, designed to
achieve a 70-85% removal rate, will be installed to control
SO2 and existing electrostatic precipitators will be
replaced with fabric filters to control PM. The project will also
involve building changes, including removal of an office building and
the attachment of two equipment buildings to the north side boiler
building. There are no physical changes being made to RPU-SLP Units 1-
3.
    The new SO2 limits incorporated from the joint Title I/
Title V document into the SIP will be 2.3 lb/mmBtu for Units 1-3 for
any unit when operating alone for all averaging times. New group limits
of 1.9 lb/mmBtu limit for the 24-hour and 1-hour averaging times and
2.3 lb/mmBtu limit for the 3-hour averaging time will apply to Units 1-
3 if more than one unit is operating on coal. These new group limits
are more stringent than the SO2 limits currently in the SIP
and will replace the TACWEF equations, which will be removed upon
approval of the SIP revision. An interim SIP limit of 2.1 lb/mmBtu will
apply to Unit 4 while the pollution control project is installed. This
limit will be

replaced by a final SIP limit of 0.6 lb/mmBtu for Unit 4 once the
pollution control project is operational.
    MPCA is currently preparing an update to the Rochester
SO2 maintenance plan, as the Rochester area was redesignated
to attainment of the SO2 NAAQS on March 9, 2001 (66 FR
14087). Section 175A of the CAA requires States to submit a revised
maintenance plan eight years after redesignation of any area as an
attainment area. MPCA has indicated that this maintenance plan update
will include nearby sources, regional sources, background sources, and
future growth. Revised air dispersion modeling was conducted for this
SIP revision using the AERMOD model with Rochester meteorological data
to ensure continued attainment of the SO2 NAAQS in the area.
Based on the modeling results, the changes at RPU-SLP described above
are projected to lower the air quality impacts from the facility,
compared to emission limits currently allowed under the 2001 SIP. The
modeling compared RPU-SLP's current operating scenario to the post-
project scenario. EPA therefore finds the SIP revision is fully
approvable because it results in a substantial decrease in
SO2 emissions at RPU-SLP from what is allowed under the 2001
SIP, and subsequent lower SO2 ambient concentrations in the
Rochester area.

3. What Is a ``Title I Condition?''

    SIP control measures were contained in permits issued to culpable
sources in Minnesota until 1990 when EPA determined that limits in
State-issued permits are not Federally enforceable because the permits
expire. The State then issued permanent Administrative Orders to
culpable sources in nonattainment areas from 1991 to February of 1996.
    Minnesota's consolidated permitting regulations, approved into the
Minnesota SIP on May 2, 1995 (60 FR 21447), include the term ``Title I
condition'' which was written, in part, to satisfy EPA requirements
that SIP control measures remain permanent. A ``Title I condition'' is
defined as ``any condition based on source-specific determination of
ambient impacts imposed for the purposes of achieving or maintaining
attainment with the [NAAQS] and which was part of the [SIP] approved by
EPA or submitted to the EPA pending approval under section 110 of the
act. * * *'' The rule also states that ``Title I conditions and the
permittee's obligation to comply with them, shall not expire,
regardless of the expiration of the other conditions of the permit.''
Further, ``any title I condition shall remain in effect without regard
to permit expiration or reissuance, and shall be restated in the
reissued permit.''
    Minnesota has also initiated using joint Title I/Title V documents
as the enforceable document for imposing emission limitations and
compliance requirements in SIPs. The SIP requirements in joint Title I/
Title V documents submitted by MPCA are cited as ``Title I
conditions,'' therefore ensuring that SIP requirements remain permanent
and enforceable. EPA reviewed the State's procedure for using joint
Title I/Title V documents to implement site-specific SIP requirements
and found it to be acceptable under both titles I and V of the CAA
(July 3, 1997 letter from David Kee, EPA, to Michael J. Sandusky,
MPCA). Further, a June 15, 2006, letter from EPA to MPCA clarifies
procedures to transfer requirements from Administrative Orders to joint
Title I/Title V documents.

II. What Action Is EPA Taking?

    EPA is approving into the Minnesota SO2 SIP for the City
of Rochester, Olmsted County, certain portions of Minnesota Air
Emission Permit No. 10900011-004, issued to RPU-SLP on August 23, 2007.
Specifically, EPA is only approving into the SIP those portions of the
joint Title I/Title V document cited as ``Title I Condition: State
Implementation Plan for SO2'' and ``Title I Condition: State
Implementation Plan for PM10.'' In addition, EPA is removing from the
Minnesota SO2 SIP all other references to Title I conditions
for RPU-SLP that are not relevant to attainment of the NAAQS.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the State plan if relevant adverse
written comments are filed. This rule will be effective February 1,
2010 without further notice unless we receive relevant adverse written
comments by January 4, 2010. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. The EPA will not institute a second
comment period. Any parties interested in commenting on this action
should do so at this time. If we do not receive any comments, this
action will be effective February 1, 2010.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. Accordingly, this
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 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 9, 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.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 1, 2010. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: November 17, 2009.
Walter W. Kovalick Jr.,
Acting Regional Administrator, Region 5.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart Y--Minnesota

0
2. In Sec.  52.1220 the table in paragraph (d) is amended by revising
the entry for ``Rochester Public Utilities, Silver Lake Plant'' to read
as follows:

Sec.  52.1220  Identification of plan.

* * * * *
    (d) * * *

                                 EPA-Approved Minnesota Source-Specific Permits
----------------------------------------------------------------------------------------------------------------
                                                     State effective
          Name of source               Permit No.          date         EPA approval date         Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Rochester Public Utilities, Silver     10900011-004           9/7/07  December 2, 2009,     Only conditions
 Lake Plant.                                                           [Insert page number   cited as ``Title I
                                                                       where the document    Condition: SIP for
                                                                       begins].              SO2'' and ``Title I
                                                                                Condition: SIP for
                                                                                PM10.''

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

* * * * *
[FR Doc. E9-28681 Filed 12-1-09; 8:45 am]