[Federal Register: July 10, 2007 (Volume 72, Number 131)]
[Notices]
[Page 37522]
[DOCID:fr10jy07-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-498-000]

Central Kentucky Transmission Company; Notice of Proposed Changes
in FERC Gas Tariff

June 29, 2007.
    Take notice that on June 27, 2007, Central Kentucky Transmission
Company (Central Kentucky) tendered for filing as part of its FERC Gas
Tariff, Original Volume No. 1, the following tariff sheets, with an
effective date of August 1, 2007:

First Revised Sheet No. 10
Original Sheet No. 10A
First Revised Sheet No. 355

    Central Kentucky states it is submitting the revised tariff sheets
to permit shippers to combine into a single service agreement, multiple
service agreements under the FTS Rate Schedule, but with different
terms of service for purposes of nominating service on its system.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-13303 Filed 7-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Notices]
[Page 54629-54631]
[DOCID:fr08se10-77]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0012; FRL-8843-3]

Notice of Receipt of Several Pesticide Petitions Filed for
Residues of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the Agency's receipt of several initial
filings of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before October 8, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://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 regulations.gov or e-
mail. The regulations.gov website 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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 docket index
available at http://www.regulations.gov. 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, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. 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:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What Action is the Agency Taking?

     EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. EPA has determined that
the pesticide petitions described in this notice contain the data or
information prescribed in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petitions.
Additional data may be needed before EPA can make a final determination
on these pesticide petitions.
     Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this notice, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://
www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerances

    1. PP 0E7731. (EPA-HQ-OPP-2010-0659). ISK BioSciences Corporation,
7470 Auburn Road, Suite A, Concord, Ohio 44077, proposes to establish a
tolerance in 40 CFR part 180 for residues of the fungicide pyriofenone,
(5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-trimethoxy-6-
methylphenyl) methanone, in or on grape at 0.2 parts per million (ppm).
A practical analytical method for pyriofenone using liquid
chromatography-mass spectrometry/MS (LC/MS/MS) is available for
analysis of grapes. This method has been confirmed through independent
laboratory validation and is available for enforcement purposes.
Contact: Heather Garvie,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    2. PP 0E7735. (EPA-HQ-OPP-2010-0583). Interregional Research
Project Number 4 (IR-4) Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08450, proposes to establish tolerances in 40 CFR part
180 for residues of the fungicide tetraconazole, 1-[2-(2,4-
dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxyl)propyl]-1 H-1,2,4-
triazole, in or on small fruit vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 0.20 ppm; and low growing berry, subgroup 13-07G at
0.25 ppm. Adequate enforcement methodology (capillary gas
chromatography with electron capture detector (GC/ECD)) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350. Contact: Sidney Jackson, (703)
305-7610, e-mail address<EMAIL_ADDRESS>     3. PP 0E7743. (EPA-HQ-OPP-2010-0621). Interregional Research
Project Number 4 (IR-4) Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08450, proposes to establish tolerances in 40 CFR part
180 for residues of the fungicide metconazole, 5-[(4-chlorophenyl)-
methyl]-2,2-dimethyl-1-(1 H -1,2,4-triazol-1-ylmethyl) cyclopentanol),
measured as the sum of cis- and trans- isomers, in or on bushberry
subgroup 13-07B at 0.35 ppm; and tuberous and

corm vegetable subgroup 1C at 0.02 ppm. Independently validated
analytical methods have been submitted for analyzing parent metconazole
residues with appropriate sensitivity for crops and processed
commodities for which a tolerance is being requested. Contact: Andrew
Ertman,<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>     4. PP 0F7711. (EPA-HQ-OPP-2010-0425). Bayer CropScience, 2 T.W.
Alexander Drive, Research Triangle Park, NC 27709, proposes to
establish tolerances in 40 CFR part 180 for residues of the insecticide
penflufen, (1H-pyrazole-4-carboxamide, N-[2-(1,3-dimethylbutyl)phenyl]-
5-fluoro-1,3-dimethyl-), in or on alfalfa, forage and hay at 0.01 ppm;
cotton, gin byproducts at 0.01 ppm; canola, borage, crambe, cuphea,
echium, flax seed, gold of pleasure, hare's ear mustard, lesquerella,
lunaria. meadowfoam, milkweed, mustard seed, oil radish, poppy seed,
rapeseed, sesame, sweet rocket, calendula, castor oil plant, Chinese
tallowtree, cottonseed, euphorbia, evening primrose, jojoba, niger
seed, rose hip, safflower, stokes aster, sunflower, tallowwood, tea oil
plant, and vernonia at 0.01 ppm; grain, cereal, group 15 at 0.01 ppm;
grain, cereal, forage, fodder and straw, group 16 at 0.01 ppm;
vegetable, legume, group 06 at 0.01 ppm; vegetable, foliage of legume,
group 07 at 0.01 ppm; and vegetable, tuberous and corm, subgroup 01C at
0.01 ppm. Tolerances are being proposed in primary crops solely for
penflufen. The analytical method involves solvent extraction,
filtration, and addition of an isotopically labeled internal standard
followed by acid hydrolysis. Quantitation is by high performance liquid
chromatography-electrospray ionization/tandem mass spectrometry (LC/MS/
MS). Contact: Marianne Lewis,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>
Amended Tolerance

     PP 0E7735. (EPA-HQ-OPP-2010-0583). Interregional Research Project
Number 4 (IR-4) Project Headquarters, Rutgers, The State University of
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08450,
proposes to delete the existing tolerance in 40 CFR 180.557 for
residues of the fungicide tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-
(1,1,2,2-tetrafluoroethoxyl)propyl]-1 H-1,2,4-triazole, in or on grape
at 0.20 ppm since grape is included in the proposed subgroup 13-07F in
2. under ``New Tolerance''. Contact: Sidney Jackson,<PHONE_NUMBER>, e-
mail address<EMAIL_ADDRESS>
New Tolerance Exemption

     PP 0F7687. (EPA-HQ-OPP-2004-0144). Stehekin, LLC, 1012 Good Lander
Drive, WA 98942, proposes to amend 40 CFR 180.920 to establish an
exemption from the requirement of a tolerance for residues of 1-
naphthaleneacetic acid, potassium and sodium salts (NAA) in or on
potato. The analytical method for NAA was submitted to the Agency under
EPA MRID number 445554-03 for the detection and measurement of the
pesticide residues. Contact: Janet Whitehurst,<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: August 30, 2010.
 G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2010-22331 Filed 9-7-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Page 56698]
[FR Doc No: 2021-22119]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP22-22-000.
    Applicants: Northwest Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Service
Agreement--Avista & Citadel to be effective 11/4/2021.
    Filed Date: 10/4/21.
    Accession Number: 20211004-5015.
    Comment Date: 5 p.m. ET 10/18/21.

    Docket Numbers: RP22-24-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--CEP Venture
911757 Eff 11-08-2021 to be effective 11/8/2021.
    Filed Date: 10/4/21.
    Accession Number: 20211004-5092.
    Comment Date: 5 p.m. ET 10/18/21.

    Docket Numbers: RP22-25-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Compliance filing: Cameron Extension Project (CP19-
512) In-Service Compliance Filing to be effective 11/8/2021.
    Filed Date: 10/4/21.
    Accession Number: 20211004-5093.
    Comment Date: 5 p.m. ET 10/18/21.

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

    Dated: October 5, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-22119 Filed 10-8-21; 8:45 am]
BILLING CODE 6717-01-P


1 Date: 16 August 2004 To: James Covington, EPA From: Cal Franz and Maureen F. Kaplan, ERG Subject: Airport Industrial Discharges   Industry Profile 1. Summary The economic analysis of increased pollution control costs   primarily for deicing effluents   will need a focus on secondary impacts not typical for other industries. The reason for this is that airports have a distinctive financial structure. They are frequently organized on a residual cost basis which means that they are legally required to recover all costs. Thus, airports do not operate in a traditional market economy. They might be envisioned as " transparent" where the costs move through the airport to those which will ultimately pay those costs. The economic analysis, therefore, needs to focus on who will bear the increased costs. While airports might have several options to recover costs ( e. g., increased concessionaire fees, increased passenger fees, and/ or increased fees on airlines), under a residual cost arrangement, the airlines ultimately assume the increased costs not otherwise paid by alternative revenue sources. The financial condition of the U. S. airline industry has deteriorated sharply since September 11, 2001. There are no obvious signs of a rapid turnaround, particularly for large commercial airlines ( see Section 6). An economic analysis of added costs for controlling airport industrial discharges will need to include an analysis of the current financial state of the airline industry as well as the airports.

2. Introduction Airport industrial discharges was identified as an industry sector currently not regulated by effluent guidelines through stakeholders' suggestions for the 2003/ 2004 effluent guidelines program plan. EPA examined discharges for this industry in the Toxics Release Inventory ( TRI) and Permit Compliance System ( PCS) databases and decided that additional data collection was needed before the Agency could determine whether there are non trivial discharges from this industry ( USEPA, 2003).

This memorandum provides an initial industry profile. Section 3 describes the subset of the airport industry of interest, provides preliminary facility counts and the number of airports belonging to small entities. Section 4 reviews airport financing and the implications for the economic analysis should EPA select this industry for an effluent guideline. Section 5 reviews options for airport capital expenditure financing, changed uses for AIP grants since September 2001, and the impact of airline bankruptcies on airport financing. Section 6 provides a brief overview of the recent financial condition of the airline industry. 2 3. Facility Counts, Ownership, and Small Entities The discharges of interest are associated with deicing and anti icing aircraft. EPA identified 211 airports with the potential for significant deicing operations based on the number of operations (

10,000 operations per year) and snowfall (

1 inch per year), see ERG, 2000. ERG downloaded the Federal Aviation Administration ( FAA) Airport Data ( 5010) and Contact Information data file for National Flight Data Center ( NFDC) facilities ( FAA, 2004a). The data exports are for effective date August 5, 2004.

ERG matched the 211 airports of interest to their owners and whether the owner was public or private by the airport code, city, and state. Airport ownership is composed of:

# Stewart International Airport which is owned National Express Group, PLC.

# University of Illinois # Andrews Air Force Base, owned by the Federal Government.

# States # Counties # Cities # Multipurpose Port Authorities or Airport Authorities The Regulatory Flexibility Act ( 5 USC Section 601) defines three types of small entities:

# small business   defined by Small Business Administration size standards # small organizations   defined as any not for profit enterprise which is independently owned and operated and is not dominant in its field.

# small governmental jurisdictions   defined as governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than 50,000.

ERG, 2004 provides details on the data sources used to identify facilities belonging to small entities. Of the 211 airports with the potential for non trivial deicing operations, 14 belong to small entities.

4. Airport Financial Management and Accounting 4.1 Overview Airport financial management is fundamentally different from most other business enterprises. This is because many airports, including the majority of large commercial airports, have traditionally used a residual cost approach to finances. Under a residual cost approach, the airlines as a group assume the financial risk for the airport by agreeing to pay any costs of running the airport not paid by other nonairline users.

Under the alternative compensatory approach, the airport assumes the financial risk of running the airport; airlines pay rates set equal to their estimated cost of using the facility. Using the compensatory approach there is no guarantee the airport will cover costs, however, the airport can keep any surplus of 1 Except in specific legal agreements signed prior to the 1982 law prohibiting such practices. Therefore a few airport owners, such as the Port Authority of New York, still legally use airport revenues to subsidize non airport activities. Periodic questions of " revenue diversion" do arise, the most notorious being the claim by the City of Los Angeles that it was owed almost $ 90 million by the Los Angeles Department of Airports for alleged unreimbursed capital and operating expenses and relating to the sale of airport property ( DOT, 1997).

3 revenues over cost and accumulate capital for future development. Many airports may use a mixture of the two approaches ( Wells, 1996).

Airport financial statements are difficult to compare between airports and with other businesses due to differences in the size and objective of different airports, the type of airport ownership ( e. g., private or public), the existence of these two fundamentally different financial approaches to operations, and legal restrictions on airport finances. For example, because most airports use a residual cost approach, they are assured of sufficient revenues from airlines to pay the cost of capital investment and are unlikely to account for depreciation on assets in a manner similar to most business enterprises. Also, airports are legally prevented from using their revenues for non airport purposes. 1 Airport financial statements thus do not meet the standards of Generally Accepted Accounting Principals ( GAAP), and an airport's revenue surplus or loss is not equivalent to profit or loss ( ERG, 1998a).

Typical airport operating statements can be divided into the following categories ( Wells, 1996):

# Operating revenues and operating expenditures on key " cost centers:"   airfield area ( e. g., runways, taxiways, aprons)   terminal area concessions ( e. g., food and beverage services, travel services such as car rentals, specialty shops, personal services, amusements, advertising, outside concessions such as terminal parking, ground transportation, and hotels)   airline leased areas ( e. g., ground equipment rentals, offices, ticket counters, cargo terminals, hangers, operations and maintenance areas)   other leased areas ( e. g., FBOs, freight forwarders, government offices, businesses in airport industrial parks, equipment and cargo terminals rented by non airline users)   other operating revenues and expenditures # Non operating revenues ( e. g., grants in aid ( AIP), interest on investments, subsidies by government, leasing of properties not related to operations)

# General and administrative expenses ( e. g., expenses of overhead services: accounting, legal, planning, public relations); at some airports ( such as small municipal airports), these expenses, including policing and firefighting expenses, may appear in the governing authority's budget, not the airport budget # Non operating expenses ( e. g., interest on outstanding debt, contributions to government)

# Depreciation 2 Wells ( 1996) claims that airports such as Los Angeles and Honolulu have approached " negative" landing fees in recent years due to overall operating surpluses.

4 Under a residual cost approach, the airport determines costs and revenues from each general operational area above, and airlines fees are set by the anticipated revenue short fall. Any surplus is returned to airlines in the form of lower fees the following year; any loss would be made up in higher fees the following year. Both terminal and landing fees may be adjusted by the airport, or landing fees only may be adjusted. 2 The compensatory approach may determine fees according to the actual cost of running the airport, or by market value. The latter is especially common for terminal concessions. A growing trend has been for airports to use a mix of the residual cost and compensatory approach. For example, terminal concessions may be operated on a compensatory approach permitting the airport to keep surpluses from concession rents and fees, while air side operations are run under the residual cost approach.

The financial and operational relationship between airlines and airport is defined in the airport use agreement. This document specifies how the risks and responsibilities of running the airport will be shared, the methods used for calculating rates for use of facilities and services, and how frequently these rates and fees may be adjusted.

4.2 Airport to Airline Cost Pass Through A significant question concerning airport finances also cannot be answered through the information provided in the FAA files: what percentage of cost increases are typically passed through to airlines in the form of higher fees? At residual cost airports, the airline is legally responsible to cover the costs of the airport; this suggests that airports pass through 100 percent of costs. To whom the costs are passed might differ by airport. Options include concessions, passenger facility charges ( PFCs), property leases, and landing fees. Airline representatives have stated that costs on airports, FBOs, and the FAA are all passed through to the airlines. Furthermore, according to the industry, landing fees   the most likely vehicle for passing through airport costs   are a significant factor in determining airline service provided to cities; an increase in landing fees can cause an airline to reduce or halt service to the airport ( ATA, 1998). Thus, two airports in close proximity to each other might increase concession fees rather than landing fees lest one airport lose business to the other airport. But landing fees remain the most likely vehicle for most airports to recover costs.

Landing fees account for roughly 2 to 3 percent of overall airline operating costs ( Wells, 1996). ATA comments that although landing fees are a relatively small percentage of airline operating costs, airport costs, including landing fees, are one of the most rapidly rising components of costs. According to ATA, any cost component is of great concern to the industry if it is rising, regardless of the level of the cost ( ATA, 1998). Furthermore, many airline operating costs are difficult for airlines to exercise direct control over in the short run. Jet fuel prices are determined by market forces and airlines have little ability to cut those costs in the short run. Similarly, labor costs are generally determined through multi year union contracts. Airlines therefore have incentive to aggressively pursue cost containment strategies for any component of operating cost over which they have leverage, including landing fees ( ERG, 1998b). Although landing fees comprise a relatively small percentage of overall operating costs, a substantial increase in landing fees can significantly impact airline operating costs. If, for example, Boston's Logan 5 Airport increased its landing fees by $ 0.50 per 1,000 lbs ( a 22 percent increase), the landing fees paid by USAirways   Logan's most frequent user   would increase by approximately $ 1.6 million per year ( AAAE, 1999; FAA, 1998; DOT, 1998).

USEPA, 2000 reports the findings from visits to several airports. What was clear was that while each airport might decide differently on the mix of groups to which the increased costs were passed ( landing fee, concessions, other leased areas, etc.), the airports either required or highly likely to pass through most, if not all, increased costs. The economic impacts for this effluent guideline, then, will be the secondary impacts rather than those for the airports. This is discussed further in Section 6 below.

5. Airport Capital Financing 5.1 Options In general, airports rely on the following sources of funds to finance capital improvements:

# Federal funding through the FAA Airport Improvement Program ( AIP).

# FAA authorized Passenger Facility Charges ( PFCs): FAA authorizes commercial airports to impose PFCs for funding certain types of capital improvements similar to those eligible for AIP funds. Airports may charge up to $ 4.50 per enplaned passenger and passengers may be charged PFCs no more than twice on each leg of a round trip journey.

# State funding: this varies widely by state; Alaska and Hawaii provide considerable assistance while other states provide minimal assistance ( e. g., New Hampshire).

# Bond market: although some city and states may fund airport expansion with general obligation bonds, or self liquidating general obligation bonds, more typically airports use tax exempt general revenue bonds. Typically airport revenue bonds have 25 30 year terms.

# Airport revenues: capital improvements funded directly from airport revenue streams, whether airside or landside.

# The airport may lease airport owned land to private individual or company who finances improvements ( e. g., airlines that build their own terminal on airport property out of airline funds .

Table 1 summarizes the sources of airport funding for capital development during 1999 2001. Federal funds make up one fifth of the revenues for capital investment. 6 Table 1 Sources of Airport Financing, 1999 2001 ($ Billions, 2001 Dollars)

Funding Source 1999 2001 Average Annual Funding ($ Billions) Percent of Total Source of Funds Airport Bonds $ 6.90 59% Usually, state and local governments or airport authorities issue tax exempt debt. Funds also include notes.

Airport Improvement Program ( AIP) grants $ 2.42 21% Congress makes funds available from the Airport and Airway Trust Fund which receives revenue from various aviationrelated taxes.

Passenger Facility Charges ( PFC) $ 1.59 13% Funds come from passenger fees of up to $ 4.50 per trip segment at commercial airports.

State and Local Contributions $ 0.44 4% Funds include state and local grants, loans, and matching funds for AIP grants.

Airport Revenue $ 0.42 4% airside or landside revenues Total $ 11.78 100%

Source: Dillingham, 2003.

5.2 AIP Grants Funds and Purposes As noted in Section 5.1, AIP grants form an important source of capital funding for airports. However, since September 11, 2001, the purposes to which the funds have been put have changed dramatically. Table 2 summarizes the difference between 2001 and 2002 AIP funding by category. That is, although total funding remained level ($ 3.2 to $ 3.3 billion), funding for security measures increased tenfold to $ 561 million with subsequent declines in all other categories.

The percent allocated to environmental purposes decreased from 12.7 percent to 9.9 percent. However, environmental purposes include noise mitigation measures and installation of noise monitoring equipment ( GAO, 2002). Thus, only a small portion of the environmental expenditures might be relevant to stormwater and de icing controls. 3The same table also listed seven airports whose revenue bonds were upgraded during the same period.

7 Table 2 Distribution of AIP Grant Funds, 2001 and 2002 Grant Award Amounts ($ Millions) Percentage of Budget Development Category 2001 2002 2001 2002 Capacity $ 517.9 $ 477.6 15.8% 14.8%

Environment $ 417.0 $ 319.8 12.7% 9.9%

Planning $ 55.5 $ 53.5 1.7% 1.7%

Reconstruction $ 740.7 $ 592.7 22.6% 18.4%

Safety $ 203.7 $ 137.5 6.2% 4.3%

Security $ 56.6 $ 561.0 1.7% 17.4%

Standards $ 968.4 $ 812.4 29.5% 25.2%

Other $ 323.7 $ 266.8 9.9% 8.3%

Totals $ 3,283 $ 3,222 100% 100%

Source: GAO, 2002.

5.3 Impacts on Airports from Recent Airline Financial Status DOT, 2003 notes that airports are in relatively sound financial health; no airport has defaulted on its general airport revenues bonds since the industry was deregulated in 1978. In contrast, more than 130 airlines filed for bankruptcy during the same period. Bankruptcy laws provide a carrier in Chapter 11 reorganization with a substantial amount of leverage over leased airport facilities in order to allow the carrier to emerge as a viable economic entity. That is, a carrier can reject its airport leases and pay only a small amount in damages to the airport.

Financial institutions are re evaluating the ability of an airport to repay debt in light of the overall decline in air travel since September 2001 and whether it is dominated by a single carrier. The perception that some airports are riskier investments than others leads to lower bond ratings and thus higher debt costs. Exhibit 1 in DOT 2003 lists 12 airports whose revenue bonds have been downgraded since September 2001 and three airports whose PFC and special facility bonds have been downgraded. 3 8 6. Financial Status of the Airlines 6.1 Current State The Air Transport Association ( ATA) provides an annual economic report on the industry ( ATA, 2003). Its members represent approximately 95 percent of the passenger and cargo traffic carried by U. S. Scheduled airlines. Table 3 presents key financial results and other data from 1998 through 2002. Although an erosion in the operating profit margin and rate of return on investment from 1998, the losses in the industry have been massive since September 2001, e. g., $ 11.3 billion in 2002. Employment dropped from by 70,000 jobs between 2001 and 2002. Preliminary estimates for 2003 show a continuing loss of $ 3.6 billion dollars ( ATA, 2004a).

Table 3 Key Financial Parameters for U. S. Airlines, 1998 2002 Financial Millions of Dollars Parameter 1998 1999 2000 2001 2002 Total Revenue $ 113,810 $ 119,455 $ 130,839 $ 115,526 $ 106,881  Passenger Revenue $ 81,052 $ 84,383 $ 93,622 $ 80,947 $ 73,238  Freight and Express Revenue $ 10,697 $ 11,415 $ 12,486 $ 12,066 $ 12,662  Mail Revenue $ 1,708 $ 1,739 $ 1,970 $ 1,063 $ 658  Charter Revenue $ 4,059 $ 4,284 $ 4,913 $ 4,449 $ 4,456  Other Revenue $ 16,294 $ 17,634 $ 17,848 $ 17,000 $ 15,825 Total Operating Expenses $ 104,528 $ 111,119 $ 123,840 $ 125,852 $ 115,450 Operating Profit ( Loss) $ 9,283 $ 8,337 $ 6,999 ($ 10,326) ($ 8,569)

Interest Income ( Expense) ($ 1,753) ($ 1,833) ($ 2,193) ($ 2,506) ($ 3,262)

Other Income ( Expense) ($ 2,682) ($ 1,226) ($ 2,320) $ 4,557 $ 536 Net Profit ( Loss) $ 4,847 $ 5,277 $ 2,486 ($ 8,275) ($ 11,295)

Operating Profit Margin (%) 8.2% 7.0% 5.3%  8.9%  8.0%

Net Profit Margin (%) 4.3% 4.4% 1.9%  7.2%  10.6%

Rate of Return on Investment (%) 12.0% 11.1% 6.4%  6.5%  9.6%

Employment ( Full Time Equivalents) 621,064 646,410 679,967 671,969 601,356 Source: ATA, 2003. 9 From 1998   i. e., the same period covered in Table 3   there have been 22 cases of an airline declaring bankruptcy ( some more than once). These are summarized in Table 4. The number and size of insolvent carriers is a cause for concern, particularly for the airports that rely on the airlines for income ( see Section 5.3).

Table 4 Recent Airline Bankruptcies Date Carrier Date Carrier 2/ 1998 Pan American World Airways 1/ 2001 Trans World Airlines 7/ 1998 Euram Flight Centre 8/ 2001 Midway Airlines 3/ 1999 Kiwi International Airlines 1/ 2002 Sun Country Airlines 6/ 1999 Sunjet International/ Myrtle Beach Jet Express 7/ 2002 Vanguard Airlines 9/ 1999 Eastwind Airlines 8/ 2002 US Airways 11/ 1999 Access Air 12/ 2002 United Airlines 2/ 2000 Tower Air 3/ 2003 Hawaiian Airlines 5/ 2000 Kitty Hawk 10/ 2003 Midway Airlines 9/ 2000 Pro Air 1/ 2004 Great Plains Airlines 9/ 2000 Fine Air Services 1/ 2004 Atlas Air/ Polar Air Cargo 12/ 2000 Legend Airlines 12/ 2000 National Airlines Source: ATA, 2004b.

6.2 Projections FAA published an aerospace forecast for fiscal years 2004 2015 ( FAA, 2004b). The Administration projects that passenger demand will return to pre September 2001 levels by 2005 with moderate growth ( e. g., an annual rate of 4.3 percent over the forecast period). FAA considers the effects of the Severe Acute Respiratory Syndrome ( SARS) epidemic as well as worries about terrorism to indicate how sensitized global air travel has become to any extraordinary event.

FAA notes three trends that have emerged after September 2001 in the commercial aviation market. First, large and what FAA calls " legacy" airlines are undergoing a major restructuring and downsizing ( see Tables 3 and 4). Second, low cost carriers are showing rapid growth, particularly in nontraditional long distance markets. Third is the marked growth in regional/ commuter carriers due, in part, to 10 downsizing among the legacy carriers. These market changes indicated a need for a study on the possible impacts of airline bankruptcies and financial conditions on airports, i. e., DOT, 2003.

Regional/ commuter airlines step into the role vacated by the large commercial airlines as they cut back on short haul routes. Part of the reason for the growth in regional/ commuter airlines is an increase in the number of code sharing agreements with the major carriers. It is now difficult for a regional/ commuter airline to compete without such agreements. FAA projects that low cost carriers and regional/ commuters could account for more than half the domestic passengers by 2015 ( FAA, 2004b).

None of this appears to bode well for the large commercial carriers usually associated with being primary customers at hub airports. FAA projections might be optimistic because they rest on a short term forecast that oil and gas prices decline throughout 2004 and 2005 ( see FAA, Table 1). At the moment, however, oil prices are reaching new heights of $ 45/ bbl ( WSJ, 2004).

7. References AAAE. 1999. American Association of Airport Executives. AAAE Survey of Airport Rates and Charges, 1997 1998. Alexandria, VA: American Association of Airport Executives.

ATA. 2004a. Air Transport Association of America. Annual Revenue and Earnings. U. S. Airlines   All Services. http:// www. airlines. org/ econ/ print. aspx? nid= 1034 Downloaded 12 August.

ATA. 2004b. Air Transport Association of America. Airline Bankruptcies: An Unofficial Compilation. http:// www. airlines. org/ econ/ print. aspx? nid= 6207 Downloaded 1 July.

ATA. 2003. Air Transport Association of America. 2003 Economic Report: A review of the U. S. Airline Industry. Air Transport Association of America: Washington, DC.

ATA. 1998. Air Transport Association of America. Meeting Summary, Air Transport Association of America, Economics Session. December 16.

Dillingham. 2003. Gerald L. Dillingham, Director, Civil Aviation Issues, U. S. General Accounting Office. Airport Finance: Past Funding Levels May Not Be Sufficient to Cover Capital Development. Testimony before the Subcommittee on Aviation, Senate Committee on Commerce, Science, and Transportation. GAO 03 497T. February 25.

DOT. 2003. U. S. Department of Transportation. Impact of Air Carriers Emerging from Bankruptcy on Hub Airports, Airport Systems and U. S. Capital Markets. December. http:// ostpxweb. dot. gov/ aviation/ domav/ dotspecterstudy. pdf Accessed 12 August 2004.

DOT. 1998. U. S. Department of Transportation. Bureau of Transportation Statistics. Office of Airline Information. Airport Activity Statistics: 1997. Washington, DC: U. S. Department of Transportation.

DOT. 1997. U. S. Department of Transportation. Office of Inspector General. Management Advisory Memorandum on City of Los Angeles' Department of Airports Revenue Retention ( Report Number: R9 FA 7 005). Washington, DC: U. S. Department of Transportation. March 7. 11 ERG. 2004. Eastern Research Group, Inc. " Airport Industrial Discharges: Number of Small Entities." Memorandum to James Covington, III, EPA dated 6 August.

ERG. 2000. Eastern Research Group, Inc. " Final Development of Estimated Loadings in Wastewater Discharges from Aircraft Deicing/ Anti icing Operations." Prepared for U. S. Environmental Protection Agency. January.

ERG. 1998a. Eastern Research Group, Inc. Telephone conversation between Wayne Heibeck, FAA Office of Airports, and Calvin Franz, ERG. September 15.

ERG. 1998b. Eastern Research Group, Inc. Economic Site Visit Report for Chicago O'Hare International Airport. Draft Final. Prepared for EPA by Eastern Research Group, Inc. November 24.

FAA. 2004a. Federal Aviation Administration. Airport Data ( 5010) and Contact Information web page. NFDC facilities data export. http:// www. faa. gov/ arp/ safety/ 5010/ index. cfm? nav= safedata and http:// www. faa. gov/ arp/ safety/ 5010/ excel/ NfdcFacilities. xls.

FAA. 2004b. Federal Aviation Administration. FAA Aerospace Forecasts: Fiscal Years 2004 2015. http:// apo. faa. gov/ foreca03/ FORECAST% 20BOOK. pdf FAA. 1998. Federal Aviation Administration. 1998 List of Cargo Aircraft: CY1998 ACAIS database. Washington, DC: U. S. Department of Transportation. http:// www. faa. gov/ arp/ A& D stat. htm.

GAO. 2002. U. S. General Accounting Office. Airport Finance: Using Airport Grant Funds for Security Projects Has Affected Some Development Projects. Washington, DC. GAO 03 027. October.

SBA. 2002. Small Business Administration. Small Business Size Standards: Size Standards by 2002 North American Industry Classification System. Federal Register 67: 56944. 6 September.

USEPA. 2003. U. S. Environmental Protection Agency. Preliminary Effluent Guidelines Program Plan for 2004/ 2005. Federal Register 68: 75515 75531. 31 December.

USEPA. 2002. U. S. Environmental Protection Agency. Preliminary Data Summary: Airport Deicing Operations ( Revised). EPA 821 R 00 016. August.

Wells. 1996. Alexander T. Wells. Airport Planning and Management. 3rd ed., New York: McGraw Hill.

WSJ. 2004. Wall Street Journal. Oil Prices. 13 August. P. B6.


[Federal Register: May 16, 2008 (Volume 73, Number 96)]
[Notices]
[Page 28451]
[DOCID:fr16my08-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-187-000]

Equitrans, L.P.; Notice of Request Under Blanket Authorization

May 7, 2008.
    Take notice that on April 24, 2008, Equitrans, L.P. (Equitrans),
225 North Shore Drive, Pittsburgh, Pennsylvania 15212, filed in Docket
No. CP08-187-000, a prior notice request pursuant to sections 157.205
and 157.210 of the Federal Energy Regulatory Commission's regulations
under the Natural Gas Act for authorization to replace approximately
9.71 miles of Line No. H-152, located in Allegheny and Washington
Counties, Pennsylvania, all as more fully set forth in the application,
which is on file with the Commission and open to public inspection. The
filing may also be viewed on the Web at 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. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Specifically, Equitrans proposes to replace approximately 9.71
noncontiguous miles of 16-inch diameter bare steel pipeline, located in
Allegheny and Washington Counties, Pennsylvania, with 16-inch diameter
coated steel pipeline. Equitrans estimates the cost of construction to
be $22,362,143. Equitrans states that the replacement project is
necessitated by the age and condition of the existing bare steel
pipeline. Equitrans asserts that there are nine segments planned for
replacement.
    Any questions regarding the application should be directed to David
K. Dewey, Vice President & General Counsel, Equitrans, L.P., 225 North
Shore Drive, Pittsburgh, Pennsylvania 15212, at<PHONE_NUMBER> or
facsimile at<PHONE_NUMBER>.
    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR
157.205) a protest to the request. If no protest is filed within the
time allowed therefore, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request shall be treated as
an application for authorization pursuant to Section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-10955 Filed 5-15-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 8, 2005 (Volume 70, Number 235)]
[Proposed Rules]
[Page 72970-72973]
[DOCID:fr08de05-29]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 86

[OAR-2004-0011; FRL-8004-8]
RIN 2060-AM32

Control of Air Pollution From New Motor Vehicles and New Motor
Vehicle Engines: Technical Amendments to Evaporative Emissions
Regulations, Dynamometer Regulations, and Vehicle Labeling

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking.

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    In the ``Rules and Regulations'' section of this Federal Register,
we are making these technical amendments as a direct final rule without
prior proposal, because we view these technical amendments as
noncontroversial revisions. We anticipate no adverse comment. We have
explained our reasons for these technical amendments in the preamble to
the direct final rule. If we receive no adverse comment, we will not
take further action on this proposed rule. If we receive adverse
comment, we will withdraw the portions of the direct final rule
receiving such comment and those portions will not take effect. We will
address all public comments in a subsequent final rule based on this
proposed rule. We will not institute a second comment period on this
action. Any parties interested in commenting must do so at this time.

DATES: Written comments must be received by January 9, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2004-
0011, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Agency Web site: http://www.epa.gov/edocket. EDOCKET,

EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket ID No. OAR-2004-0011, Environmental
Protection Agency, Mailcode: 6102T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
     Hand Delivery: Docket ID No. OAR-2004-0011, Environmental
Protection Agency, EPA Docket Center (EPA/DC), Air and Radiation
Docket, Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC
20460. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. OAR-2004-0011.
EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at http://www.epa.gov/edocket
, 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 EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the federal regulations.gov Web sites are
``anonymous access'' systems, 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 EDOCKET or 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 EDOCKET index
at http://www.epa.gov/edocket. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the Docket, EPA/DC, EPA West, Room B102, 1301 Constitution
Ave., NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
fax number for the Air Docket and Reading Room for OAR-2004-0011 is
(202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Lynn Sohacki, Certification and
Compliance Division, Office of Transportation and Air Quality, 2000
Traverwood, Ann Arbor, MI 48105; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA is taking direct final action to make
changes to certain provisions of the evaporative and refueling emission
regulations for light-duty vehicles, light-duty trucks and heavy-duty
vehicles up to 14,000 pounds GVWR, the four-wheel drive dynamometer
test provisions, and the vehicle labeling regulations. The evaporative
changes are intended to (1) Reduce manufacturers' certification
evaporative/refueling test burden, (2) clarify existing evaporative/
refueling requirements and (3) better harmonize Federal evaporative/
refueling test procedures with California evaporative/refueling test
procedures. These actions do not affect manufacturer liability;
manufacturers must still comply with applicable evaporative standards.
Today's action retains EPA's authority to perform all three evaporative
tests (two-day, three-day, and ORVR) on any test vehicle, including
certification and in-use vehicles. The dynamometer changes are intended
to amend outdated regulations to now include four-wheel drive
provisions. The labeling changes are intended to amend regulations to
remove outdated information. Today's action does not change the
stringency of these existing programs.
    In the ``Rules and Regulations'' section of today's Federal
Register, we are promulgating these revisions as a direct final rule
without a prior proposal because we view this as a noncontroversial
action and anticipate no adverse comment. We have explained our reasons
for this action in the preamble to the direct final rule. This proposal
incorporates by reference all of the reasoning, explanation, and
regulatory text from the direct final rule. For further information,
including the regulatory text for this proposal, please refer to the
direct final rule that is located in the ``Rules and Regulations''
section of this Federal Register publication. The direct final rule
will be effective on February 6, 2006, unless we receive adverse
comment by January 9, 2006, or if we receive a request for a public
hearing by December 23, 2005. If we receive no adverse comment, we will
not take further action on this proposed rule. If we receive adverse
comment on one or more distinct amendments, paragraphs, or sections of
this rulemaking, we will publish a timely

withdrawal of those items only in the Federal Register indicating which
provisions are being withdrawn due to adverse comment. We may address
all adverse comments in a subsequent final rule based on this proposed
rule. We will not institute a second comment period on this action. Any
parties interested in commenting must do so at this time. Any distinct
amendment, paragraph, or section of today's rulemaking for which we do
not receive adverse comment will become effective on the date set out
above, notwithstanding any adverse comment on any other distinct
amendment, paragraph, or section of the direct final rule.
    Regulated Entities: Entities potentially affected by this action
are those that manufacture and sell motor vehicles in the United
States. The table below gives some examples of entities that may have
to comply with the regulations. However, since these are only examples,
you should carefully examine these and other existing regulations in 40
CFR part 86. If you have any questions, please call the person listed
in the FOR FURTHER INFORMATION CONTACT section above.

----------------------------------------------------------------------------------------------------------------
                                                  NAICS codes                        Examples of potentially
                   Category                           \a\        SIC codes \b\         regulated entities
----------------------------------------------------------------------------------------------------------------
Industry......................................          336111            3711  Automobile and Light Duty Motor
                                                        336112                   Vehicle Manufacturing; Heavy
                                                        336120                   Duty Truck Manufacturing.
----------------------------------------------------------------------------------------------------------------
\a\ North American Industry Classification System (NAICS).
\b\ Standard Industrial Classification (SIC) system code.

    Access to Rulemaking Documents Through the Internet: Today's action
is available electronically on the date of publication from EPA's
Federal Register Internet Web site listed below. Electronic copies of
this preamble, regulatory language, and other documents associated with
today's final rule are available from the EPA Office of Transportation
and Air Quality Web site, listed below, shortly after the rule is
signed by the Administrator. These services are free of charge, except
any cost that you already incur for connecting to the Internet.
     EPA Federal Register Web site: http://www.epa.gov/docs/fedrgstr/epa-air/
 (either select a desired date or use the Search

feature).
     EPA Office of Transportation and Air Quality Web site:
http://www.epa.gov/otaq/ (look in What's New or under specific

rulemaking topic).
    Please note that due to differences between the software used to
develop the documents and the software into which the documents may be
downloaded, changes in format, page length, etc., may occur.

I. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency is required to determine whether this regulatory action would be
``significant'' and therefore subject to review by the Office of
Management and Budget (OMB) and the requirements of the Executive
Order. The order defines a ``significant regulatory action'' as any
regulatory action that is likely to result in a rule that may:
     Have an annual effect on the economy of $100 million or
more or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or state, local, or tribal governments or
communities;
     Create a serious inconsistency or otherwise interfere with
an action taken or planned by another agency;
     Materially alter the budgetary impact of entitlements,
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or,
     Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    Pursuant to the terms of Executive Order 12866, we have determined
that this final rule is not a ``significant regulatory action.''

B. Paperwork Reduction Act

    The Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq., and
implementing regulations, 5 CFR Part 1320, do not apply to this action
as it does not involve the collection of information as defined
therein.
    Today's action may reduce testing and reporting burden by allowing
the option for waivers and/or alternative test procedures. The current
average annual reporting burden is listed as 542,118 hours and
$10,889,000 for 153 respondents by the Office of Management and Budget
for light-duty and heavy-duty vehicles. If a manufacturer does not
implement any of today's actions, the reporting burden will not change.
Otherwise, the burden may be reduced by implementing today's actions
but will vary depending upon the options and/or alternative methods
chosen. For instance, utilizing the option to waive the two-diurnal
diurnal-plus-hot-soak will reduce testing burden by approximately 48
hours and $5,000 per vehicle. Since no alternative procedures for the
running loss test or canister loading have been approved at this time,
the burden reduction cannot be quantified, but they will, in the
future, result in decreases in hours and costs. The other options
described in today's action cannot be quantified but would not result
in any additional burden.
    Burden means 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. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions.

    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration regulations at 13 CFR 121.201; (2)
a small governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities.'' 5 U.S.C.
Sections 603 and 604. Thus, an agency may conclude that a rule will not
have a significant economic impact on a substantial number of small
entities if the rule relieves regulatory burden, or otherwise has a
positive economic effect on all of the small entities subject to the
rule.
    Today's rule revises certain provisions of the Evaporative
Emissions Compliance Procedure (58 FR 16002, March 24, 1993) and the
Onboard Refueling Vapor Recovery Procedure (58 FR 16262, April 6,
1994), such that regulated entities will find it less burdensome to
demonstrate compliance with the requirements of the evaporative
emissions and ORVR test requirements. More specifically, today's action
makes minor revisions to clarify regulations and reduces burdens for
manufacturers without reducing stringency. In addition, today's rule
revises the dynamometer test provisions (40 CFR 86.135-90, 40 CFR
86.159-00, 40 CFR 86.160-00) and the Vehicle Labeling requirements (40
CFR 86.098-35, 40 CFR 86.1807-01), such that regulated entities will
find it less burdensome to test four-wheel drive vehicles and vehicle
labels will reflect current information rather than out-dated
information. We have therefore concluded that today's final rule will
relieve regulatory burden for all small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for federal agencies to assess the
effects of their regulatory actions on state, local, and tribal
governments, and the private sector. Under section 202 of the UMRA, we
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``federal mandates'' that
may result in expenditures to state, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more for
any single year. Before promulgating a rule for which a written
statement is needed, section 205 of the UMRA generally requires us to
identify and consider a reasonable number of regulatory alternatives
and adopt the least costly, most cost-effective, or least burdensome
alternative that achieves the objectives of the rule. The provisions of
section 205 do not apply when they are inconsistent with applicable
law. Moreover, section 205 allows us to adopt an alternative that is
not the least costly, most cost-effective, or least burdensome
alternative if we provide an explanation in the final rule of why such
an alternative was adopted.
    Before we establish any regulatory requirement that may
significantly or uniquely affect small governments, including tribal
governments, we must develop a small government plan pursuant to
section 203 of the UMRA. Such a plan must provide for notifying
potentially affected small governments, and enabling officials of
affected small governments to have meaningful and timely input in the
development of our regulatory proposals with significant federal
intergovernmental mandates. The plan must also provide for informing,
educating, and advising small governments on compliance with the
regulatory requirements.
    Today's action contains no federal mandates for state, local, or
tribal governments as defined by the provisions of Title II of the
UMRA. The rule imposes no enforceable duties on any of these
governmental entities. Nothing in the rule will significantly or
uniquely affect small governments.
    We have determined that today's action does not contain a federal
mandate that may result in estimated expenditures of more than $100
million to the private sector in any single year. This action has the
net effect of revising certain provisions of the Evaporative Emissions
rule, Dynamometer regulations, and Labeling regulations. Therefore, the
requirements of the UMRA do not apply to this action.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires us to develop an accountable process to ensure
``meaningful and timely input by state and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects 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.
    Under Section 6 of Executive Order 13132, we may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the federal government provides the funds necessary to pay the direct
compliance costs incurred by state and local governments, or we
consults with state and local officials early in the process of
developing the proposed regulation. We also may not issue a regulation
that has federalism implications and that preempts state law, unless
the Agency consults with state and local officials early in the process
of developing the proposed regulation.
    Section 4 of the Executive Order contains additional requirements
for rules that preempt state or local law, even if those rules do not
have federalism implications (i.e., the rules will not have substantial
direct effects 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). Those
requirements include providing all affected state and local officials
notice and an opportunity for appropriate participation in the
development of the regulation. If the preemption is not based on
express or implied statutory authority, we also must consult, to the
extent practicable, with appropriate state and local officials
regarding the conflict between state law and federally protected
interests within the Agency's area of regulatory responsibility.
    Today's action does not have federalism implications. It will not
have substantial direct effects 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,
as specified in Executive Order 13132. Today's action revises certain
provisions of earlier rules

that adopted national standards to control vehicle evaporative
emissions, dynamometer test provisions, and labeling requirements. The
requirements of the rule will be enforced by the federal government at
the national level. Thus, the requirements of Section 6 of the
Executive Order do not apply to today's action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This proposed rule does not
have tribal implications, as specified in Executive Order 13175.
Today's proposed rule does not uniquely affect the communities of
American Indian tribal governments since the motor vehicle requirements
for private businesses in today's rule will have national
applicability. Furthermore, today's rule does not impose any direct
compliance costs on these communities and no circumstances specific to
such communities exist that will cause an impact on these communities
beyond those discussed in the other sections of today's document. Thus,
Executive Order 13175 does not apply to today's action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that (1) is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that we have reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, section 5-501 of the Executive Order directs us to
evaluate the environmental health or safety effects of the planned rule
on children, and explain why the planned regulation is preferable to
other potentially effective and reasonably feasible alternatives
considered by us.
    Today's action is not subject to the Executive Order because it is
not an economically significant regulatory action as defined by
Executive Order 12866. Furthermore, today's action does not concern an
environmental health or safety risk that we have reason to believe may
have a disproportionate effect on children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    Today's action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Section 12(d) of Public Law 104-113, directs us to
use voluntary consensus standards in our regulatory activities unless
it would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) developed or adopted by voluntary consensus standards
bodies. The NTTAA directs us to provide Congress, through OMB,
explanations when we decide not to use available and applicable
voluntary consensus standards.
    Today's action references technical standards adopted by us through
previous rulemakings. No new technical standards are established in
today's rule. The standards referenced in today's action involve the
measurement of vehicle evaporative emissions, the allowance for four-
wheel dynamometer test capabilities in certification and in-use
testing, and labeling requirements revisions.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as amended 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 Congress and the comptroller General of the United
States. We will submit a report containing today's 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). Today's action will be effective February 6, 2006.

II. Statutory Provisions and Legal Authority

    Statutory authority for today's final rule is found in the Clean
Air Act, 42 U.S.C. 7401 et seq., in particular, sections 202 of the
Act, 42 U.S.C. 7521. Today's action is being promulgated under the
administrative and procedural provisions of Clean Air Act section
307(d), 42 U.S.C. 7607(d).

List of Subjects in 40 CFR Part 86

    Environmental protection, Administrative practice and procedure,
Motor vehicle pollution.

    Dated: November 29, 2005.
Stephen L. Johnson,
Administrator.
[FR Doc. 05-23713 Filed 12-7-05; 8:45 am]

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[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Notices]
[Pages 67696-67698]
[FR Doc No: 2022-24457]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-2257]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
9, 2023. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 8, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 9, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-E-2257 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; XCOPRI.'' Received

comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug product becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, XCOPRI
(cenobamate) indicated for treatment of partial-onset seizures in adult
patients. Subsequent to this approval, the USPTO received a patent term
restoration application for XCOPRI (U.S. Patent No. 7,598,279) from SK
Biopharmaceuticals Co., Ltd., and the USPTO requested FDA's assistance
in determining the patent's eligibility for patent term restoration. In
a letter dated April 5, 2021, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of XCOPRI represented the first permitted commercial marketing
or use of the product. Thereafter, the USPTO requested that FDA
determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
XCOPRI is 5,326 days. Of this time, 4,850 days occurred during the
testing phase of the regulatory review period, while 476 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
August 12, 2005. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
12, 2005.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: November 21,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for XCOPRI (NDA 212839) was initially submitted on
November 21, 2018.
    3. The date the application was approved or the effective date of
approval for a drug product recommended for control under the
Controlled Substances Act: March 10, 2020. FDA has verified the
applicant's claim that NDA 212839 was approved on November 21, 2019,
and that the date of issuance of the interim final rule controlling the
drug under section 201(j) of the Controlled Substances Act (21 U.S.C.
811(j)) was March 10, 2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

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

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24457 Filed 11-8-22; 8:45 am]
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