[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Rules and Regulations]
[Pages 43082-43088]
[FR Doc No: 2010-17776]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-R03-SFUND-2010-0436; FRL-9177-8]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Partial Deletion of the Letterkenny Army
Depot Southeastern (SE) Area and Letterkenny Army Depot Property
Disposal Office (PDO) Area Superfund Sites

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) Region III is
publishing a direct final Notice of Deletion of portions of the
Letterkenny Army Depot Southeastern (SE) Area and Letterkenny Army
Depot Property Disposal Office (PDO) Area (Sites), located in
Chambersburg, PA, from the National Priorities List (NPL). The NPL,
promulgated pursuant to section 105 of the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA) of 1980, as amended,
is an appendix of the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). This direct final partial deletion is being
published by EPA with the concurrence of the Commonwealth of
Pennsylvania, through the Pennsylvania Department of Environmental
Protection (PADEP), because EPA has determined that all appropriate
response actions at these identified parcels under CERCLA, other than
operation, maintenance, and five-year reviews, have been completed.
However, this partial deletion does not preclude future actions under
Superfund.
    This partial deletion pertains to the soil and groundwater of
parcels 24, 27, 28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90,
and 3-91. All other parcels within the site boundaries of Letterkenny
Army Depot SE and PDO Areas will remain on the NPL and are not being
considered for deletion as part of this action.

DATES: This direct final partial deletion is effective September 21,
2010 unless EPA receives adverse comments by August 23, 2010. If
adverse comments are received, EPA will publish a timely withdrawal of
the direct final partial deletion in the Federal Register informing the
public that the partial deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-R03-
SFUND-2010-0436, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>, Attn: Gerald Hoover.
     Mail or Hand Delivery to: U.S. Environmental Protection
Agency, Region III, Attn: Gerald Hoover (3HS11), 1650 Arch Street,
Philadelphia, PA 19103-2029. Phone:<PHONE_NUMBER>. Business Hours:
Mon. thru Fri.--9 a.m. to 4 p.m.
    Instructions: Direct your comments to Docket ID no. EPA-R03-SFUND-
2010-0436. 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.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 at:

U.S. EPA Region III, Library, 2nd Floor, 1650 Arch Street,
Philadelphia, PA, 19103-2029. Phone:<PHONE_NUMBER>. Business Hours:
Mon. thru Fri.--8 a.m. to 5 p.m.
Letterkenny Army Depot, Building 14, Chambersburg, PA 17201-4150. POC:
Bryan Hoke. Phone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Gerald Hoover, Remedial Project
Manager (3HS11), U.S. Environmental Protection Agency, Region III, 1650
Arch Str., Philadelphia, PA 19103-2029,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Partial Deletion Procedures
IV. Basis for Site Partial Deletion
V. Partial Deletion Action

I. Introduction

    EPA Region III is publishing this direct final Notice of Partial
Deletion of portions of the Letterkenny Army Depot Southeastern (SE)
Area and Letterkenny Army Depot Property Disposal Office (PDO) Area
(Sites) from the National Priorities List (NPL). This partial deletion
pertains to the soil and groundwater of parcels 24, 27, 28, 2-53, 2-
53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91. The NPL
constitutes Appendix B of 40 CFR part 300, which is the Oil and
Hazardous Substances Pollution Contingency Plan (NCP), which EPA
promulgated pursuant to Section 105 of the Comprehensive Environmental
Response, Compensation and Liability Act (CERCLA) of 1980, as amended.
EPA maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment. Sites
on the NPL may be the subject of remedial actions financed by the
Hazardous Substance Superfund (Fund). This partial deletion of the
Letterkenny Army Depot SE and PDO Areas is proposed in accordance with
40 CFR 300.425(e) and is consistent with the Notice of Policy Change:
Partial Deletion of Sites Listed on the National Priorities List. 60 FR
55466 (Nov. 1, 1995). As described in 300.425(e)(3) of the NCP, a
portion of a site deleted from the NPL remains eligible for Fund-
financed remedial action if future conditions warrant such actions.
    Because EPA considers this action to be noncontroversial and
routine, this action will be effective September 21, 2010 unless EPA
receives adverse comments by August 23, 2010. Along with this direct
final Notice of Partial Deletion, EPA is co-publishing a Notice of
Intent for Partial Deletion in the ``Proposed Rules'' section of the
Federal Register. If adverse comments are received within the 30-day
public comment period on this partial deletion action, EPA will publish
a timely withdrawal of this direct final Notice of Partial Deletion
before the effective date of the partial deletion and the partial
deletion will not take effect. EPA will, as appropriate, prepare a
response to comments and continue with the deletion process on the
basis of the Notice of Intent for Partial Deletion and the comments
already received. There will be no additional opportunity to comment.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses procedures that EPA is using
for this action. Section IV discusses the parcels 24, 27, 28, 2-53, 2-
53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 of the Letterkenny
Army Depot SE and PDO Areas and demonstrates how they meet the deletion
criteria. Section V discusses EPA's action to partially delete the
parcels from the NPL unless adverse comments are received during the
public comment period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the Commonwealth, whether any of the following
criteria have been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-
year reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure. EPA conducts such five-year reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates it is appropriate. Whenever there is a significant
release from a site deleted from the NPL, the deleted site may be
restored to the NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to the deletion of parcels 24, 27,
28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 of the
Letterkenny Army Depot SE and PDO Areas:
    (1) EPA has consulted with the Commonwealth of Pennsylvania prior
to developing this direct final Notice of Partial Deletion and the
Notice of Intent for Partial Deletion co-published in the ``Proposed
Rules'' section of the Federal Register.
    (2) EPA has provided the Commonwealth 30 working days for review of
this notice and the parallel Notice of Intent for Partial Deletion
prior to their publication today, and the Commonwealth, through the
Pennsylvania Department of Environmental Protection (PADEP), has
concurred on the partial deletion of the Sites from the NPL, with the
condition that future use of the deleted parcels remains commercial/
industrial.
    (3) Concurrently with the publication of this direct final Notice
of Partial Deletion, a notice of the availability of the parallel
Notice of Intent for Partial Deletion is being published in a major
local newspaper, The Chambersburg Public Opinion. The newspaper notice
announces the 30-day public comment period concerning the Notice of
Intent for Partial Deletion of the Sites from the NPL.
    (4) The EPA placed copies of documents supporting the partial
deletion in the deletion docket and made these items available for
public inspection and copying at the Sites' information repositories
identified above.
    (5) If adverse comments are received within the 30-day public
comment period on this partial deletion action, EPA will publish a
timely notice of withdrawal of this direct final Notice of Partial
Deletion before its effective date and will prepare a response to
comments and continue with the deletion process on the basis of the
Notice of Intent for Partial Deletion and the comments already
received.
    Deletion of a portion of a site from the NPL does not itself
create, alter, or revoke any individual's rights or obligations.
Deletion of a portion of a site from the NPL does not in any way alter
EPA's right to take enforcement actions, as appropriate. The NPL is
designed primarily for informational purposes and to assist EPA
management. Section 300.425(e)(3) of the NCP states that the deletion
of a portion of a site from the NPL does not preclude eligibility for
further response

actions, should future conditions warrant such actions.

IV. Basis for Partial Site Deletion

    The following information provides EPA's rationale for deleting
portions of the Sites from the NPL:

Site Location

    Letterkenny Army Depot (LEAD) is located in south-central
Pennsylvania in Franklin County, 5 miles north of the Borough of
Chambersburg. The Depot covers 19,243 acres, most of which is devoted
to ammunition storage. LEAD was the subject of two listings on the
National Priorities List (NPL). The first was for the Southeastern (SE)
Area, and the second was for the Property Disposal Office (PDO) Area.
These two areas are separated by a major groundwater/surface-water
drainage divide. The industrial and maintenance areas, which are
primarily located in the southeastern corner of LEAD, encompass
approximately 2,500 acres and include warehousing, vehicle storage,
administration, industrial/maintenance, recreational activities, and
housing. The infrastructure of this area includes roads; permanent,
semi-permanent, and temporary structures; and utilities. Approximately
1,235 acres at LEAD have been designated for ``realignment'' under the
Base Realignment and Closure (BRAC) initiative. ``Realignment'' means
that the mission at LEAD is changing and approximately 1,235 acres at
LEAD have been designated for release and transfer (i.e., ``to-be-
excessed'' or to transfer ownership). The BRAC area is concentrated in
the southeastern portion of LEAD, but is located in both the PDO and SE
Areas. The BRAC area is being transferred to the Letterkenny Industrial
Development Authority (LIDA) in phases. To date, LEAD has completed
three parcel transfer phases, covering 761 acres. The Phase I parcels
were transferred in 1998. The Phase II parcels were transferred in
2002. The Phase III parcels were transferred in 2004.

Site Background and History

    LEAD was originally established as an ammunition storage facility,
Letterkenny Ordnance Depot, in 1942. A vehicle maintenance program was
started in 1947. In subsequent years additional missions were added and
the facility was renamed the Letterkenny Army Depot in 1962. The
principal missions at LEAD currently include maintenance, modification,
storage, and demilitarization operations on tactical missiles,
conventional ammunition, and tactical wheeled vehicles. Operations
conducted at LEAD involved cleaning, stripping, plating, lubrication,
demolition, chemical/petroleum transfer/storage, and washout/
deactivation of ammunition. Many of these missions/activities involved
the use and/or disposal of chlorinated solvents, primarily
trichloroethene (TCE) and 1,1,1-trichloroethane (TCA), along with
petroleum hydrocarbons and other solvents.
    The Letterkenny Army Depot SE Area (EPA ID PA6213820503) was listed
on the NPL in the final rule appearing in the 7/22/87 Federal Register
(52 FR 27620-27642).
    The Letterkenny Army Depot PDO Area (EPA ID PA2210090054) was
listed on the NPL in the final rule appearing in the 3/13/89 Federal
Register (54 FR 10512-10517).
    The parcels to be deleted from the NPL are all in an area known as
the Southern Martinsburg Shale Region (SMSR), which is an area
underlain by the Martinsburg Shale. These parcels are located in both
the SE Area and the PDO Area. All of these parcels have been
transferred from the Army to the LIDA under the BRAC Act of 1995. These
parcels have been incorporated into the Cumberland Valley Business Park
which is a commercial/industrial business park. The property consists
of industrial land, developed land, small stands of trees, open grassy
areas, commercial recreational areas (golf course and community
center), administration buildings, and former military housing. No
wetlands are located within the parcels, and no Federal or state
threatened or endangered species are known or suspected to exist within
the parcels. Land located within an approximately 0.5-mile radius of
the parcels includes industrial land to the north (including land to be
retained by the Army), an industrial area to the east (other BRAC sites
as well as land to be retained by the Army), agricultural land to the
south, and industrial land to the west (other BRAC property). The
parcels are accessible to the general public via Coffey Avenue, which
was transferred to LIDA and is maintained by the local townships.
    This partial deletion covers the following parcels: 24, 27, 28, 2-
53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 (See Table
1).

                 Table 1--LIDA/Parcels and the Associated Media Included in the Partial Deletion
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           LIDA Parcel No.              Parcel No.       Decision document             Contaminated media
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24, 2-24B...........................              24  Phase I ROD, SEP 1998..  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
27, 2-27B, 3-27C, 3-27D.............              27  Phase I ROD, SEP 1998..  Soil & Groundwater.
                                                      Phase II ROD, JULY 2001  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
28, 3-28B...........................              28  Phase I ROD, SEP 1998..  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
2-53................................            2-53  Phase II ROD, JULY 2001  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
2-53L...............................           2-53L  Phase II ROD, JULY 2001  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
2-54................................            2-54  Phase II ROD, JULY 2001  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
2-54L...............................           2-54L  Phase II ROD, JULY 2001  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
2-70................................            2-70  Phase II ROD, JULY 2001  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.
2-70L...............................           2-70L  Phase II ROD, JULY 2001  Soil & Groundwater.
                                                      Phase III ROD, AUG 2003  Soil & Groundwater.

3-89-1, 3-89-2, 3-89-3, 3-89-4, 3-89-           3-89  Phase III ROD, AUG 2003  Soil & Groundwater.
 5, 3-89-6, 3-89-7, 3-89-8, 3-89-9,
 3-89-10, 3-89-11, 3-89-12, 3-89-13,
 3-89-14, 3-89-15, 3-89-16, 3-89-17,
 3-89-18, 3-89-19, 3-89-20, 3-89-21,
 3-89-22, 3-89-23, 3-89-24, 3-89-25,
 3R-89-26, 3R-89-27, 3R-89-28, 3R-89-
 29.
3-90................................            3-90  Phase III ROD, AUG 2003  Soil & Groundwater.
3-91................................            3-91  Phase III ROD, AUG 2003  Soil & Groundwater.
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The location of these parcels within the boundaries of the SE and PDO
sites can be seen on the map located in the site repositories.

Remedial Investigation and Feasibility Study (RI/FS)--Phase I Parcels

Parcel 24--Building 500 (Part of Soil SE OU 8)
    Parcel 24, which includes Building 500 and adjacent lands, was
identified through historical aerial photographs as having been used
for open vehicle storage early in LEAD's operation (post World War II).
Two test trenches were completed in this parcel, and one sample was
analyzed for Target Analyte List (TAL) metals and total petroleum
hydrocarbons (TPH). The only compound that exceeded the screening
criteria was arsenic, which slightly exceeded the EPA Region III risk-
based concentration (RBC). EPA and PADEP, along with the Army, as part
of the BRAC Cleanup Team (BCT), agreed that the detected concentration
did not warrant further remedial action for industrial use. Arsenic is
a naturally occurring metal, and arsenic results obtained at LEAD are
not inconsistent with the published background concentrations for this
metal in Pennsylvania. Residential and child-intense use scenarios were
not evaluated.
Parcel 27 and Parcel 28
    No evidence of soil contamination was identified for these two
parcels and therefore no further work was necessary.
    At the time of the RI/FS for the Phase I Parcels, it was believed
that there was groundwater contamination underlying all of the Phase I
parcels. The human health risk assessment showed unacceptable risk if
groundwater contact and use were unrestricted. The FS evaluated
institutional controls as a remedy to restrict the property for
commercial and industrial use only and to prevent exposure to the
underlying groundwater.

Selected Remedy--Phase I Parcels

    The Phase I Parcels ROD was signed in September 1998. The selected
remedy in the Phase I ROD was institutional controls. This was a final
remedy with respect to soils, and an interim remedy for groundwater.
The selected remedy included the following components:
    [dec222] Restricting the property for commercial and industrial use
only.
    [dec222] Not permitting soil excavation activities below a depth of
3 feet above the water table without prior approval of the Army.
    [dec222] Not permitting construction of any subsurface structure
for human occupation without the prior approval of the Army, PADEP, and
the EPA.
    [dec222] Restricting access or use of the groundwater underlying
the property without the prior written approval of the Army, PADEP, and
the EPA.

Remedial Investigation and Feasibility Study (RI/FS)--Phase II Parcels

Parcels 2-53, 2-54, and 2-70 (Phase II Parcels)
    No evidence of soil contamination was identified for these three
parcels and therefore no further work was necessary.
    At the time of the Phase II transfer, it was believed that the
groundwater underlying all of the Phase II parcels was contaminated
with or potentially contaminated with volatile organic compounds. To
expedite transfer, the Army and LIDA defined the Phase II parcels to
exclude the groundwater. The Phase II parcels are defined to include
only the surface structures and soil to a depth of 8 feet below ground
surface (ft bgs), which is above the seasonal high groundwater table.
The FS evaluated institutional controls as a remedy to prevent exposure
to the underlying groundwater.

Selected Remedy--Phase II Parcels

    The Phase II Parcels ROD was signed in July 2001. The Phase II ROD
determined that no action is necessary to protect public health or
welfare, or the environment from the soil at parcels 2-53, 2-54 and 2-
70. Because of the suspected groundwater contamination throughout the
Phase II parcels, the selected interim remedy for groundwater in the
Phase II ROD consisted of land use controls. The land use controls
include the following restrictions:
    [dec222] Prohibiting soil excavation, digging, drilling, or other
soil-disturbing activities below a depth of 3 ft above the water table
without the prior approval of the Army.
    [dec222] Prohibiting access to or the use of the groundwater
underlying the Phase II parcels without the prior approval of the Army,
PADEP, and EPA.
    [dec222] Prohibiting construction of any subsurface structure for
human occupation without the prior approval of the Army, PADEP, and
EPA.
    LIDA's final reuse plan calls for industrial/commercial use for the
majority of the Phase II parcels. There are zoning restrictions imposed
by Greene Township to preclude residential use of land that includes
Parcels 2-53, 2-54, and 2-70. However, those restrictions are
independent of the NPL status of the Site and are not a result of
environmental contamination.

Remedial Investigation and Feasibility Study (RI/FS)--Phase III Parcels

Soil
    Parcel 3-89:
    Parcel 3-89 comprises the majority of the Phase III parcels/SMSR
area and is located in both the PDO and SE Areas. The parcel consists
of approximately 191 acres on the northern side of Carbaugh Avenue and
the western side of Coffey Avenue. Soil investigations were conducted
at the Open Vehicle Storage Area, Former Uncurbed Aboveground Storage
Tank (AST) North of Building 532, and the Backwash Discharge Area from
the Water Treatment Plant. The soil investigations are summarized in
the following paragraphs.
Open Vehicle Storage Area (OVSA) Site (Part of Soil OUs PDO OU 6 and SE
OU 8)
    The OVSA comprises the majority of Parcel 3-89. From approximately
1947 and continuing until the spring of 1998, the OVSA site was used
for the storage of military vehicles. The most recent past practice of
storage required that the

vehicles be drained of fluids (such as diesel fuel, oil, and other
engine fluids) before being stored. However, interviews with former
employees indicate that the vehicles were formerly stored ``wet,''
meaning that they were stored with the fluids still in the vehicle, and
that the vehicles' fluids may have leaked onto the ground before they
were refurbished.
    Remedial Investigations were conducted at the OVSA site in 1998,
1999, and 2000. The investigations showed possible risks associated
with elevated levels of a group of semivolatile organic compounds
(SVOCs) referred to as polycyclic aromatic hydrocarbons (PAHs) in soil.
An engineering evaluation/cost analysis (EE/CA) was written to evaluate
the need for a removal action. Based on the EE/CA findings a Removal
Action was conducted in 2000. The cleanup levels used for the removal
action were developed based on a future commercial/industrial post-
removal reuse of the site. Approximately 45,000 tons of soil
contaminated with PAHs were excavated and disposed of at approved off-
site waste disposal facilities. Confirmatory sampling conducted after
the removal action showed that the remaining concentrations of PAHs
were at or below risk-based standards. A post-removal risk assessment
was performed assuming a future commercial/industrial use as well as a
potential future residential (unrestricted) use. The risk assessment
showed concentrations of chemicals found in site soils, sediments,
surface water, and groundwater posed no unacceptable risks to people,
plants, or animals based on current and future commercial/industrial
reuse. Risks to people based on a theoretical future residential use
are within acceptable limits.
Former Uncurbed Aboveground Storage Tank (AST) North of Building 532
Site (Part of PDO OU 6)
    This is a small site that consists of a former aboveground storage
tank (AST) area. Initially, there was an uncurbed single-walled AST
(275 gallons) located north of Building 532 that stored gasoline used
to fuel golf carts. This single-walled AST was replaced by a double-
walled AST. It is unknown how long the single-walled AST was in
service. The soils near the uncurbed AST were not investigated prior to
the change in ASTs. The double-walled AST was still in place at the
time of the remedial investigation in 1999; however the double-walled
AST has subsequently been removed because the golf course converted to
electric golf carts.
    An investigation was completed to determine if the operation of the
former AST at the site had caused a release of contaminants to site
soil. Soil sampling was performed in April 1999. Soil borings, soil
sampling and analysis, data validation, and surveying were performed.
The investigation results did not indicate any chemicals of concern
(COCs) in soil and there were no potential sources of groundwater
contamination found. Only two chemicals (acetone and lead) were
identified as chemicals of potential concern (COPCs) based on a
comparison of maximum chemical concentrations to the lowest regulatory
residential benchmarks. However, the remedial investigation/risk
assessment showed that concentrations of chemicals found in site soils
pose no unacceptable risks to people based on current and likely future
commercial/industrial use. Risks to people are also within acceptable
limits based on a theoretical future residential use. There is minimal
habitat available capable of sustaining plants and animals at this
site; therefore, ecological risks were not evaluated.
Backwash Discharge Area From the Water Treatment Plant Site (Part of SE
OU 8)
    This site is located in the eastern part of the parcel along Coffey
Avenue, near the water treatment plant for the potable water supply. In
the past, sediments that accumulated in the raw water line were flushed
out in the western area of the site. In the past, fluffy material
(referred to as ``flocculant''), which primarily consists of suspended
solids removed from the water during the treatment process, was
discharged to the eastern area of the site for settling.
    An investigation was completed to determine if the former water
treatment plant flocculant and backwash sediment disposal practices had
caused a release of contaminants to site soil and sediments. Field
activities were performed in October 1998. Soil borings, soil and
drainage ditch soil sampling and analysis, sediment sampling and
analysis, data validation, and surveying were performed. The
investigation results did not indicate any COCs in soil and there were
no potential sources of groundwater contamination found. Various metals
were identified as COPCs based on a comparison of maximum chemical
concentrations to the lowest regulatory residential benchmarks.
However, the remedial investigation/risk assessment showed that
concentrations of chemicals found in site soils pose no unacceptable
risks to people, plants, or animals based on current and likely future
commercial/industrial uses. Risks to people are also within acceptable
limits based on a theoretical future residential use.
Parcel 3-90
    Parcel 3-90 is approximately 8 acres in size and is located south
of Carbaugh Avenue and west of Coffey Avenue. Parcel 3-90 is located in
both the PDO and SE Areas. There are no structures on this parcel. This
parcel is currently open land and has been an open area in the past
with no apparent storage or industrial activities. No further work was
necessary.
Parcel 3-91
    Parcel 3-91 is approximately 1.5 acres in size and is located east
of Coffey Avenue and north of Texas/Innovation Avenue in the
southeastern corner of the SMSR. Parcel 3-91 is located entirely within
the SE Area. There are no structures on Parcel 3-91. This parcel
consists entirely of the western portion of the Building 400 Series
Fire Training Area (FTA) site where industrial activities occurred. The
Building 400 Series FTA area had been reportedly used in the past for a
short period of time as a fire-fighting training area where a large
metal pan was placed on the ground and filled with various flammable
liquids, which were ignited. There was no record of the exact location
of the pan, years of use, or when or if the pan was removed from the
area when training activities ended. Historical aerial photographs from
1949 and 1957 show several disturbed places in this area. Based on
knowledge of typical fire-training activities at LEAD, materials burned
at the site may have included waste oils. There were no structures or
material/waste storage on the site at the time of the remedial
investigation in 1998. The only structures in the vicinity of the site
were several old barracks/office buildings, which are still located
near the site.
    An investigation was completed to determine if the former fire
training activities had caused a release of contaminants to site soil.
Field activities were performed in September 1998. A geophysical
survey, test trenching, soil sampling and analysis, data validation,
and surveying were performed. The investigation results did not
indicate any COCs in soil and there were no potential sources of
groundwater contamination found. One VOC (acetone), two SVOCs (PAHs),
various metals, and polychlorinated dibenzo-p-dioxins/polychlorinated
dibenzofurans (PCDDs/PCDFs) were identified as

COPCs based on a comparison of maximum chemical concentrations to the
lowest regulatory residential benchmarks. However, the remedial
investigation/risk assessment showed that concentrations of chemicals
found in site soils pose no unacceptable risks to people, plants, or
animals based on current and likely future commercial-industrial use.
Risks to people are also within acceptable limits based on a
theoretical future residential use.

Groundwater

SMSR Groundwater
    As stated above, all of the parcels in this partial deletion are in
the SMSR. The SMSR contains an area of shale bedrock surrounded by
downgradient limestone bedrock. This shale bedrock is generally more
resistant to weathering than the surrounding limestone formations and
therefore, forms the ``highland'' or elevated ridge areas. The SMSR
straddles the boundary between the PDO and SE Area NPL Sites. Based on
the geologic and topographic upgradient setting and the lack of
industrial activities within the SMSR it was thought that the SMSR
could be unaffected by the known and potential VOC sources located
downgradient of the SMSR. Therefore a groundwater investigation was
initiated in 1999 to prove that the SMSR was not impacted by any
previous industrial activities at Letterkenny. Four rounds of
groundwater sampling were conducted in late 1999 through 2000 and then
in 2002. Results of the sampling showed that there is no VOC
groundwater contamination in the SMSR. Without VOC groundwater
contamination there is no potential for vapor intrusion risk throughout
the SMSR. A screening level risk assessment showed that risks to people
based on current and future commercial/industrial use are within
acceptable limits. Risks to people based on a possible, but unlikely,
residential use (including human consumption of site groundwater) are
within acceptable limits. Based on the finding of no VOC contaminated
groundwater, the PDO portion of the SMSR was redefined as PDO OU 7 and
the SE portion was redefined as SE OU 13.
Parcels 2-53L, 2-54L, and 2-70L
    These parcels consist of land underneath parcels 2-53, 2-54, and 2-
70, which were previously transferred as part of the Phase II BRAC
property transfer at LEAD. These parcels consist of land starting 8 ft.
below ground surface and extending to the center of the earth. They are
located in the southern part of the SMSR/Phase III area within SE OU
13. As stated above, in the Phase II transfer, the entire land area was
not originally transferred because it was thought the groundwater
located underneath the land was potentially contaminated with VOCs.
These parcels were investigated as part of the SMSR groundwater
investigation described previously. The Army has completed its
investigation and risk assessment for the SMSR groundwater and found no
environmental concerns at the site. The top portions of these parcels
were transferred with an interim remedy for groundwater consisting of
restrictions on soil excavation and groundwater use because at that
time it was thought that the groundwater underneath the parcels was
contaminated. The Phase III ROD stated that the soil excavation and
groundwater restrictions could be removed.

Selected Remedy--Phase III Parcels

Soil
    As stated above, all parcels subject to this partial deletion are
part of the SMSR for Parcel 3-89, the Army, EPA, and PADEP have
determined that risks to people, plants, and animals from potential
contact with soils/sediments were acceptable at the OVSA, Former
Uncurbed AST North of Building 532, and the Backwash Discharge Area
sites and that no action is necessary to protect public health or
welfare or the environment. For the OVSA site, this conclusion is based
on the conditions of the site following the removal action that was
performed in 2000 when PAH-contaminated soil was removed from the site.
There were no environmental concerns in Parcels 3-90 and 3-91.
Groundwater
    Based on the findings of the SMSR groundwater investigation, there
is no VOC groundwater contamination and thus no unacceptable risks from
groundwater in this area.
    The Phase III ROD was signed in August 2003. Based on the results
of the remedial investigations and risk assessments it was determined
that No Further Action was necessary for the Phase III Parcels under
CERCLA. The No Further Action remedy applies to the SMSR groundwater
(PDO OU 7 and SE OU 13) and to the soils (PDO OU 6 and SE OU 8). In
addition the ROD stated that no further action was necessary for the
groundwater underlying Phase I Parcels 24, 27, 28 and Phase II Parcels,
2-53, 2-54, 2-70 and the underlying Parcels 2-53L, 2-54L, and 2-70L
because they are a part of SE OU 13.

Response Actions/Cleanup Goals/Operation & Maintenance

    There are no response actions, cleanup goals, or operation &
maintenance due to the No Further Action decision in the Phase III ROD
for both soils and groundwater. Land use controls restrict the use of
Phase I parcels to commercial and industrial use only and prohibit
residential use.

Five-Year Review(s)

    EPA concurred with the Army's first Five-Year Review for the PDO
Area on March 12, 2007. EPA concurred on the first Five-Year Review for
the SE Area in November 2001 and the second Five-Year Review for the SE
Area on June 24, 2008.
    In the 2007 Five-Year Review for the PDO Area, it was determined
that the No Further Action Remedy for PDO OU 7 and a portion of PDO OU
6 is still considered protective of human health and the environment.
This Five-Year Review did not find any issues relating to the parcels
included in this partial deletion.
    In the 2008 Five-Year Review for the SE Area, it was determined
that the No Further Action Remedy for SE OU 13 and a portion of SE OU 8
is still considered protective of human health and the environment.
This Five-Year Review did not find any issues relating to the parcels
included in this partial deletion.
    Pursuant to CERCLA section 121(c) and the NCP, the next PDO Area
five-year review will be conducted in 2012 and the next SE Area five-
year review will be conducted in 2013 to ensure other OUs at each
respective Superfund Site where waste was left in place are protective
of human health and the environment.

Community Involvement

    Public participation activities have been satisfied as required in
CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42
U.S.C. 9617. Documents in the deletion docket which EPA relied on for
recommendation of the deletion from the NPL are available to the public
in the information repositories.
    Public participation related to parcels in deletion package:

--Phase I Proposed Plan public meeting held on April 7, 1998 to present
the proposed remedy for the Phase I Parcels.
--Phase II Proposed Plan public meeting held on February 22, 2001 to
present the proposed remedy for the Phase II Parcels.
--Phase III Proposed Plan public meeting held on April 23, 2003 to

present the proposed remedy for the Phase III Parcels.

Determination That the Criteria for Deletion Have Been Met

    No further response action under CERCLA is appropriate. EPA has
determined based on the investigations conducted at these parcels and
documented by the 3 RODs described above, that the Army has implemented
all appropriate response actions required. Through the previous PDO and
SE areas five-year reviews, EPA has also determined that the Phase III
Parcels No Further Action remedy is considered protective of human
health and the environment and, therefore, taking of additional
remedial measures is not necessary. Other procedures required by 40 CFR
300.425(e) are detailed in Section III.

V. Deletion Action

    The EPA, with concurrence dated March 2, 2010 of the Commonwealth
of Pennsylvania through the Pennsylvania Department of Environmental
Protection, has determined that all appropriate response actions under
CERCLA have been completed. Therefore, EPA is deleting parcels 24, 27,
28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 of the
Letterkenny Army Depot SE and PDO Areas Sites from the NPL.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication. This action will
be effective September 21, 2010 unless EPA receives adverse comments by
August 23, 2010. If adverse comments are received within the 30-day
public comment period, EPA will publish a timely withdrawal of this
direct final notice of partial deletion before the effective date of
the partial deletion and it will not take effect. EPA will prepare a
response to comments and continue with the deletion process on the
basis of the notice of intent to partially delete and the comments
already received. There will be no additional opportunity to comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: July 12, 2010.
William C. Early,
Acting Regional Administrator, Region III.

0
For the reasons set out in this document, 40 CFR part 300 is amended as
follows:

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority:  33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR 1987 Comp., p. 193.

0
2. Table 2 of Appendix B to part 300 is amended by revising the entries
under Pennsylvania for ``Letterkenny Army Depot (SE Area),
Chambersburg'' and ``Letterkenny Army Depot (PDO Area), Franklin
County'' to read as follows:

Appendix B to Part 300--National Priorities List

                                       Table 2--Federal Facilities Section
----------------------------------------------------------------------------------------------------------------
                 State                             Site name                   City/County           Notes (a)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
PA....................................  Letterkenny Army Depot (SE      Chambersburg............               P
                                         Area).

                                                  * * * * * * *

                                                  * * * * * * *
PA....................................  Letterkenny Army Depot (SE      Franklin County.........               P
                                         Area).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(a)* * *
*P= Sites with partial deletion(s).

[FR Doc. 2010-17776 Filed 7-22-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 140 (Monday, July 24, 2017)]
[Notices]
[Page 34306]
[FR Doc No: 2017-15426]

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

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: ER16-1914-001.
    Applicants: Patua Acquisition Company, LLC.
    Description: Notice of Non-Material Change in Status of Patua
Acquisition Company, LLC.
    Filed Date: 7/17/17.
    Accession Number: 20170717-5130.
    Comments Due: 5 p.m. ET 8/7/17.

    Docket Numbers: ER17-1636-003.
    Applicants: Great River Hydro, LLC.
    Description: Notice of Non-Material Change in Status of Great River
Hydro, LLC.
    Filed Date: 7/17/17.
    Accession Number: 20170717-5124.
    Comments Due: 5 p.m. ET 8/7/17.

    Docket Numbers: ER17-2101-000.
    Applicants: Deseret Generation & Transmission Co-operative, Inc.
    Description: Sec.  205(d) Rate Filing: OATT Attachment 7/8 Sec.
17.3 Amend. to be effective 9/15/2017.
    Filed Date: 7/17/17.
    Accession Number: 20170717-5041.
    Comments Due: 5 p.m. ET 8/7/17.

    Docket Numbers: ER17-2102-000.
    Applicants: Midcontinent Independent System Operator, Inc., Union
Electric Company.
    Description: Sec.  205(d) Rate Filing: 2017-07-17_SA 3032 Ameren-
City of Hannibal Construction Agreement to be effective 6/29/2017.
    Filed Date: 7/17/17.
    Accession Number: 20170717-5051.
    Comments Due: 5 p.m. ET 8/7/17.

    Docket Numbers: ER17-2103-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
MidAmerican Energy Company, ITC Midwest LLC.
    Description: Sec.  205(d) Rate Filing: 2017-07-17_SA 3031_MEC-ITCM
Hills-Montezuma FCA to be effective 9/16/2017.
    Filed Date: 7/17/17.
    Accession Number: 20170717-5077.
    Comments Due: 5 p.m. ET 8/7/17.

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

    Dated: July 18, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-15426 Filed 7-21-17; 8:45 am]
 BILLING CODE 6717-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

			Issued by the Department of Transportation on August 27, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-15905

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Laker Airways (Bahamas) Limited						Date Filed:  August 8,
2003

Relief requested:  Exemption from 49 U.S.C. 41301 to conduct scheduled
foreign air transportation of persons,

property and mail between Freeport, The Bahamas, and Houston, Texas, on
a coterminal basis with currently authorized

U.S.-Bahamas services.

If renewal, date and citation of last action:  New authority

Applicant representative:  Pierre Murphy<PHONE_NUMBER>

DOT analyst:  Shelita Smith<PHONE_NUMBER>

Responsive pleadings:  The City of Houston and the Greater Houston
Partnership filed an answer in support of Laker’s request.

	DISPOSITION

Action:  Approved									Action date:  August 27, 2003

Effective dates of authority granted:  August 27, 2003 – August 27,
2004

Basis for approval (bilateral agreement/reciprocity):  Reciprocity

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (attached)  X  Foreign air carrier
permit conditions (Order 96-6-45)

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
____________________________________________________________

We found that the applicant was qualified to perform its proposed
operations.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that  (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its Principal Security Inspector (PSI) to advise the PSI of its
plans and to find out whether the Transportation Security Administration
has determined that security is adequate to allow such airport(s) to be
served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

08/2003


[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60827-60829]
[FR Doc No: 2021-24065]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-2124]

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

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for SEVENFACT 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
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 3, 2022.
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 3, 2022. 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. Electronic comments
must be submitted on or before January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service

acceptance receipt is 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-2124 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SEVENFACT.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product SEVENFACT
(coagulation factor VIIa (recombinant)-jncw (eptacog beta)). SEVENFACT
is indicated for the treatment and control of bleeding episodes
occurring in adults and adolescents (12 years of age and older) with
hemophilia A or B with inhibitors. Subsequent to this approval, the
USPTO received a patent term restoration application for SEVENFACT
(U.S. Patent No. 9,029,316) from Laboratoire Francais du Fractionnement
et des Biotechnologies S.A. (LFB S.A.), and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated January 4, 2021, FDA advised the USPTO
that this human biological product had undergone a regulatory review
period and that the approval of SEVENFACT 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
SEVENFACT is 2,785 days. Of this time, 1,518 days occurred during the
testing phase of the regulatory review period, while 1,267 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 (21 U.S.C. 355(i))

became effective: August 18, 2012. The applicant claims August 17,
2012, as the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was August 18, 2012, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): October 13, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for
SEVENFACT (BLA 125641) was initially submitted on October 13, 2016.
    3. The date the application was approved: April 1, 2020. FDA has
verified the applicant's claim that BLA 125641 was approved on April 1,
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 482 days of patent term extension.

III. Petitions

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

    Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24065 Filed 11-3-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Rules and Regulations]
[Pages 6559-6561]
[FR Doc No: 2011-2604]

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

40 CFR Part 52

[EPA-R03-OAR-2010-0552; FRL-9262-7 ]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; 2002 Base Year Emissions Inventory, Reasonable Further
Progress Plan, Contingency Measures, Reasonably Available Control
Measures, and Transportation Conformity Budgets for the Pennsylvania
Portion of the Philadelphia-Wilmington-Atlantic City 1997 8-Hour
Moderate Ozone Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Pennsylvania. The revision being
approved contains a 2002 base year emissions inventory, a reasonable
further progress (RFP) plan, RFP contingency measures demonstration,
and reasonably available control measure (RACM) demonstration for the
Pennsylvania portion of the Philadelphia-Wilmington-Atlantic City
moderate 1997 8-hour ozone nonattainment area. This rulemaking applies
only to the Pennsylvania portion of this multi-state nonattainment
area--an area that also lies in part in New Jersey, Maryland, and
Delaware. EPA is simultaneously approving transportation conformity
motor vehicle emissions budgets (MVEBs) associated with this same SIP
revision. EPA is approving this SIP revision because it satisfies Clean
Air Act (CAA) requirements for the 2002 emissions inventory, RFP, RACM,
RFP contingency measures, and transportation conformity requirements--
as defined by the CAA for areas classified as moderate nonattainment
for the 1997 8-hour ozone national ambient air quality standard
(NAAQS). EPA is approving the SIP revision in accordance with the
requirements of the CAA and EPA regulations.

DATES: This final rule is effective on March 9, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2010-0552. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly available, i.e.,
confidential business information (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 through http://www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Pennsylvania Department of Environmental Protection, Bureau of Air
Quality Control, P.O. Box 8468, 400 Market Street, Harrisburg,
Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Brian Rehn,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Throughout this document, whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA. On November 5, 2010 (75 FR 68251), EPA published a
notice of proposed rulemaking (or proposed rulemaking) for the
Commonwealth of Pennsylvania. The notice of proposed rulemaking
proposed EPA's approval of Pennsylvania's 2002 base year emissions
inventory, RFP plan, RFP contingency measures, RACM, and MVEBs for the
Commonwealth's portion of the Philadelphia-Wilmington-Atlantic City
moderate 1997 8-hour ozone nonattainment area. EPA is approving the SIP
revision because it satisfies the emissions inventory, RFP, RACM, RFP
contingency measures, and transportation conformity requirements

of section 110 and part D of the CAA and associated EPA regulations.
This SIP revision was formally submitted by the Pennsylvania Department
of Environmental Protection (PA DEP) on August 29, 2007, and was
formally amended by PA DEP on December 10, 2009 and again on April 12,
2010.

II. Summary of SIP Revision

    The SIP revision (and subsequent SIP amendments) address the
emissions inventory, RFP, RACM, and RFP contingency measures
requirements for the 1997 8-hour ozone NAAQS for the Pennsylvania
portion of the Philadelphia-Wilmington-Atlantic City 8-hour ozone
moderate nonattainment area. The SIP revision also establishes MVEBs
for 2008. Other specific requirements of Pennsylvania's August 29, 2007
SIP revision (as amended in December 2009 and April 2010) for the
Philadelphia-Wilmington-Atlantic City 8-hour ozone nonattainment area
and EPA's rationale for our proposed action are explained in the
November 5, 2010 proposed rulemaking and will not be restated here. A
more detailed description of the August 2007 SIP revision, as well as
the substance of each of the subsequent SIP amendments is discussed in
detail in EPA's November 5, 2010 proposed rulemaking. No public
comments were received on EPA's November 2010 proposed rulemaking.

III. Final Action

    EPA is approving the 2002 base year emissions inventory; the 2008
ozone projected emission inventory; the 2008 RFP plan; RFP contingency
measures; RACM analysis; and 2008 transportation conformity budgets for
the Pennsylvania portion of the Philadelphia-Wilmington-Atlantic City
8-hour ozone nonattainment area, contained in Pennsylvania's August 29,
2007 SIP revision (as formally amended by Pennsylvania in December 2009
and April 2010) for the Philadelphia-Wilmington-Atlantic City 8-hour
ozone nonattainment area. The SIP revision satisfies the requirements
for 1997 8-hour ozone NAAQS nonattainment areas classified as moderate
and demonstrates reasonable further progress in reducing ozone
precursors.

IV. Statutory and Executive Order Reviews

A. General Requirements

    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 CAA; 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.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    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 April 8, 2011. 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 to approve the emission inventory, RFP demonstration,
RACM determination, RFP contingency measures, and MVEBs 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, Nitrogen dioxide, Ozone,
Volatile organic compounds.

    Dated: January 24, 2011.
W.C. Early,
Acting Regional Administrator, Region III.

    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 NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by
adding, at the end of the table, entries for ``Reasonable Further
Progress Plan (RFP), Reasonably Available Control Measures, and RFP
Contingency Measures''; 2002 Base Year Emissions Inventory for Volatile
Organic Compounds (VOC), Nitrogen Oxides (NOX), and Carbon
Monoxide (CO)''; and ``2008 RFP Transportation Conformity Motor Vehicle
Emission Budgets'' to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non-regulatory SIP        Applicable      State submittal                            Additional
            revision              geographic area          date        EPA approval date        explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Reasonable Further Progress      Pennsylvania       8/29/07, 12/10/    2/7/11 [Insert
 Plan (RFP), Reasonably           portion of the     09, 4/12/10).      page number
 Available Control Measures,      Philadelphia-                         where the
 and RFP Contingency Measures.    Wilmington-                           document begins].
                                  Atlantic City,
                                  PA-DE-MD-NJ 1997
                                  8-hour ozone
                                  moderate
                                  nonattainment
                                  area.
2002 Base Year Emissions         Pennsylvania       8/29/07, 12/10/    2/7/11 [Insert
 Inventory for Volatile Organic   portion of the     09, 4/12/10.       page number
 Compounds (VOC), Nitrogen        Philadelphia-                         where the
 Oxides (NOX), and Carbon         Wilmington-                           document begins].
 Monoxide (CO).                   Atlantic City,
                                  PA-DE-MD-NJ 1997
                                  8-hour ozone
                                  moderate
                                  nonattainment
                                  area.
2008 RFP Transportation          Pennsylvania       8/29/07, 12/10/    2/7/11 [Insert
 Conformity Motor Vehicle         portion of the     09, 4/12/10.       page number
 Emission Budgets.                Philadelphia-                         where the
                                  Wilmington-                           document begins].
                                  Atlantic City,
                                  PA-DE-MD-NJ 1997
                                  8-hour ozone
                                  moderate
                                  nonattainment
                                  area.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
3. Section 52.2036 is amended by revising the section heading and by
adding paragraph (o) to read as follows:

Sec.  52.2036  Base Year Emissions Inventory.

* * * * *
    (o) EPA approves as a revision to the Pennsylvania State
Implementation Plan the 2002 base year emissions inventories for the
Pennsylvania portion of the Philadelphia-Wilmington-Atlantic City, PA-
DE-MD-NJ 1997 8-hour ozone moderate nonattainment area submitted by the
Secretary of the Pennsylvania Department of Environmental Protection on
August 29, 2007 (as formally amended by Pennsylvania on December 10,
2009 and on April 12, 2010). This submittal consists of the 2002 base
year point, area, non-road mobile, and on-road mobile source emission
inventories for this area, for the following pollutants: Volatile
organic compounds (VOC), carbon monoxide (CO) and nitrogen oxides
(NOX).

0
4. Section 52.2037 is amended by adding paragraphs (o) and (p) to read
as follows:

Sec.  52.2037  Control strategy plans for attainment and rate-of-
progress: Ozone.

* * * * *
    (o) EPA approves revisions to the Pennsylvania State Implementation
Plan consisting of the 2008 reasonable further progress (RFP) plan,
reasonably available control measure demonstration, and contingency
measures for the Pennsylvania portion of the Philadelphia-Wilmington-
Atlantic City, PA-DE-MD-NJ 1997 8-hour ozone moderate nonattainment
area submitted by the Secretary of the Pennsylvania Department of
Environmental Protection on August 29, 2007 (as formally amended by
Pennsylvania on December 10, 2009 and April 12, 2010).
    (p) EPA approves the following 2008 RFP motor vehicle emissions
budgets (MVEBs) for the Pennsylvania portion of the Philadelphia-
Wilmington-Atlantic City, PA-DE-MD-NJ 1997 8-hour ozone moderate
nonattainment area submitted by the Secretary of the Pennsylvania
Department of Environmental Protection on August 29, 2007 (as formally
amended by Pennsylvania on December 10, 2009):

Transportation Conformity Emissions Budgets for the Pennsylvania Portion of the Philadelphia-Wilmington-Atlantic
                                             City, PA-DE-MD-NJ Area
----------------------------------------------------------------------------------------------------------------
                                                                                Effective date of
   Type of control strategy SIP           Year          VOC (TPD)        NOX (TPD)     adequacy determination or
                                                                                SIP approval
----------------------------------------------------------------------------------------------------------------
Rate of Progress Plan.............            2008            61.09           108.78   January 5, 2009 (73 FR
                                                                                77682), published
                                                                                December 19, 2008.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-2604 Filed 2-4-11; 8:45 am]
BILLING CODE 6560-50-P


MEMORANDUM

DATE: 11/21/14

FROM: 		Ken Mitchell/EPA Region 4

TO:CLEAN POWER PLAN FOR EXISTING POWER PLANTS; DOCKET ID: OAR - 2013-0602

SUBJECT:DISCUSSION OF THE CLEAN POWER Plan at a Symposium on the EPA's Proposed rules on Carbon Reduction organized by the Jacksonville Electric Authority (JEA)

SUMMARY:
REGION 4 PROVIDED INFORMATION ON THE CLEAN POWER PLAN to participants at a Symposium on the
EPA's Proposed rules on Carbon Reduction organized by the Jacksonville Electric Authority in
Jacksonville, FL, on September 25, 2014.  The Clean Power Plan for Existing Power Plants was
proposed on June 2, 2014.
ATTENDEES:

EPA
Ken Mitchell/EPA R4

External Stakeholders
Michael Hightower/JEA Board of Directors
Paul McElroy/JEA
Jeff Holmstead/Bracewell and Giuliani
Theresa Pugh/APPA
Approximately 50 other attendees

ATTACHMENT


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36485-36486]
[FR Doc No: 2022-13116]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-16-000]

Georgia-Pacific Consumer Operations LLC; Notice of Availability
of the Environmental Assessment for the Proposed GPC Pipeline
Abandonment Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the GPC
Pipeline Abandonment Project, proposed by Georgia-Pacific Consumer
Operations LLC (GPC) in the above-referenced docket. GPC requests
authorization to abandon in-place approximately 19.5 miles of eight-
inch-diameter natural gas transmission pipeline and auxiliary
facilities located in Union Parish, Louisiana and Ashley County,
Arkansas, and abandon by removal all aboveground facilities associated
with the pipeline. The pipeline and auxiliary facilities have been
idled since August 2019.
    The EA assesses the potential environmental effects of the GPC
Pipeline Abandonment Project (Project) in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed project, with appropriate
mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    The Commission mailed a copy of the Notice of Availability for the
EA to federal, state, and local government representatives and
agencies; elected officials; environmental and public interest groups;
Native American tribes; potentially affected landowners and other
interested individuals and groups; and newspapers and libraries in the
project area. The EA is only available in electronic format. It may be
viewed and downloaded from the FERC's website (www.ferc.gov), on the
natural gas environmental documents page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). In
addition, the EA may be accessed by using the eLibrary link on the
FERC's website. Click on the eLibrary link (https://elibrary.ferc.gov/eLibrary/search), select ``General Search'' and enter the docket number
in the ``Docket Number'' field (i.e., CP22-16). Be sure you have
selected an appropriate date range. For assistance, please contact FERC
Online Support at [email protected] or toll free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>.
    The EA is not a decision document. It presents Commission staff's
independent analysis of the environmental issues for the Commission to
consider when addressing the merits of all issues in this proceeding.
Any person wishing to comment on the EA may do so. Your comments should
focus on the EA's disclosure and discussion of potential environmental
effects, reasonable alternatives, and measures to avoid or lessen
environmental impacts. The more specific your comments, the more useful
they will be. To ensure that the Commission has the opportunity to
consider your comments prior to making its decision on this project, it
is important that we receive your comments in Washington, DC on or

before 5:00 p.m. Eastern Time on July 13, 2022.
    For your convenience, there are three methods you can use to file
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or [email protected]. Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. This is an easy method for submitting brief, text-only
comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to FERC Online. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP22-
16-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Filing environmental comments will not give you intervenor status,
but you do not need intervenor status to have your comments considered.
Only intervenors have the right to seek rehearing or judicial review of
the Commission's decision. At this point in this proceeding, the
timeframe for filing timely intervention requests has expired. Any
person seeking to become a party to the proceeding must file a motion
to intervene out-of-time pursuant to Rule 214(b)(3) and (d) of the
Commission's Rules of Practice and Procedures (18 CFR 385.214(b)(3) and
(d)) and show good cause why the time limitation should be waived.
Motions to intervene are more fully described at https://www.ferc.gov/ferc-online/ferc-online/how-guides.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: June 13, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-13116 Filed 6-16-22; 8:45 am]
BILLING CODE 6717-01-P


Acceptable/Guideline
NOAEL = 10 mg/kg/day.
LOAEL = 100 mg/kg/day based on hematologic changes associated with histopathological changes in liver and spleen.
870.4200

Chronic/ Carcinogenicity
(rat)
45651506 (1995);
0, 25, 700, or 20,000 ppm test material;
M:  0, 1.1, 30.6, and 884.2 mg/kg/day
F:  0, 1.4, 39.5, and 1113.5 mg/kg/day
Acceptable/Guideline
NOAEL (M/F) = 1.1/1.4 mg/kg/day.
LOAEL (M/F) = 30.6/39.5 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative mild anemia.

No Evidence of Carcinogenicity
870.4300

Chronic/ Carcinogenicity
(mouse)
45651507/45877901 (2000/2003);
0, 30, 450, or 7000 ppm test material;
M:  0, 3.6, 53.4, or 800.0 mg/kg/day
F:  0, 4.3, 63.3, or 913.4 mg/kg/day
Acceptable/Guideline
NOAEL (M/F) = 3.6/4.3 mg/kg/day.
LOAEL (M/F) = 53.4/63.3 mg/kg/day based on increased erythrocyte turnover due to hemoglobin oxidation and resulting in a mild anemia.

No Evidence of Carcinogenicity
870.5100
Salmonella typhimurium and  Escherichia coli Reverse Mutation Assay
44961013 (1997);
0, 312.5, 625, 1250, 2500, or 5000 μg/plate in the presence and absence of metabolic activation (+-S9)
Acceptable/Guideline
Novaluron, tested up to the limit of solubility (2500 μg/plate) and the limit dose (5000 μg/plate), was not cytotoxic with or without S9 activation in four S. typhimurium strains and one strain of E. coli, and did not induce a genotoxic response in any strain.
870.5100
Salmonella typhimurium- bacterial reverse gene mutation assay
45030003 (1986);
0, 10, 33, 100, 333, 1000, or 3333 μg/plate in the presence and absence of mammalian metabolic activation (+-S9)
Acceptable/Guideline
Novaluron, tested up to the limit of solubility (3333 μg/plate), was not cytotoxic with or without S9 activation in five S. typhimurium strains, and did not induce a genotoxic response in any strain.
870.5300
Gene Mutation
45638321(1989);
0, 50, 100, 125, 150, 175, or 200 μg/mL with and without metabolic activation (S9-mix) in two independent assays.
Acceptable/Guideline
There was no evidence of biologically significant induction of mutant colonies over background.
870.5375

In vitro mammalian chromosome aberration test
44961015 (1992);
40, 200, and 1000 μg/mL, with and without metabolic activation (+-S9)
Acceptable/Guideline
Novaluron produced no evidence of clastogenic activity in primary human lymphocytes, in the presence or absence of S9 activation.
870.5395

Mammalian erythrocyte micronucleus test in mice
45638322(1989);
0, 1250, 2500, or 5000 mg/kg body weight
Acceptable/Guideline
There was no statistically significant increase in the frequency of micronucleated polychromatic erythrocytes in mouse bone marrow at any dose or harvest time.
870.5500

Mutagenicity - Rec assay with Bacillus subtilis
44961014 (1998);
50, 150, 500, 1,500, or 5,000 μg/plate, with and without mammalian metabolic activation (+-S9)
Acceptable/Guideline
Novaluron was equivocal for bacterial DNA damage in the absence of S9 activation, and negative for bacterial DNA damage in the presence of S9 activation.
870.5550

Unscheduled DNA Synthesis in HeLa S3 Human Epitheliod cells
45030002 (1988);
0.125, 0.25, 0.5, 1, 2, 4, 8, 16, 32, 64, 128, or 256 μg/mL (+-S9)
Acceptable/Guideline
Novaluron was considered not to show any evidence of causing DNA damage to HeLa S3 epithelioid cells in this unscheduled DNA synthesis test for mutagenic potential.
870.6200a

Acute neurotoxicity screening battery
45082601 (1999);
0, 200, 650, 2000 mg novaluron/kg
Acceptable/Guideline
NOAEL = 650 mg/kg/day.
LOAEL = 2000 mg/kg/day based on clinical signs (piloerection, irregular breathing), FOB parameters (increased head swaying, abnormal gait) and neuropathology (sciatic and tibial nerve degeneration).
870.6200b

Subchronic neurotoxicity screening battery
46086204 (2002);
0, 17.5/20.5, 174/207, 1752/2000 mg/kg/day
(M/F)
Acceptable/Guideline
NOAEL (M/F) = 1752/2000 mg/kg/day.
LOAEL = not established.
870.7485

Metabolism and pharmacokinetics
(rat)
45638401 (2000), 45638323 (1998);
single dose of 2 mg/kg or 1000 mg/kg, or 14 multiple 2 mg/kg/day doses of unlabeled novaluron (Lot no. 970211/4, 99.3% chemical purity) followed by a single dose of radiolabeled novaluron.
Acceptable/Guideline
Novaluron exhibited marginal absorption (16-18%), relatively rapid and complete excretion within 48 hours primarily via the feces and to a lesser extent via urine in rat.  Biliary contribution for fecal excretion appears to be insignificant.  Absorption appeared to be approaching saturation at high doses.  Peak plasma concentration occurred at 2-5 hours.  Urinary metabolite profiles revealed 15 components and 8 components following administration of [chlorophenyl-[14]C]novaluron or [difluorophenyl-[14]C]novaluron, respectively.  The most prevalent urinary metabolite was 2,6-difluorobenzoic acid represented the majority of the urinary radioactivity.  Other components individually represented no more than 5.9% of the dose and most represented considerably less than 1%.  Parent compound was the most prevalent contributor in the feces.  The fecal metabolite profile revealed two metabolites; 3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline and 1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea.  Quantitatively, these were minor components accounting for <2% of the dose.  In the repeated-dose group, some tissues such as fat contained measurable radioactivity at 168 hours post dose but did not appear to suggest significant potential for bioaccumulation or sequestration at the doses tested.
870.7600
Dermal penetration (rat)
45638415 (2000);
1.0, 0.067, 0.0048, or 0.0003 mg/cm[2]
Acceptable/Guideline
Recovery of administered radioactivity was an acceptable 90.19-105.26%.  The maximum total absorbed dose (expressed as percent of administered dose and determined as the sum of radioactivity in excreta, cage wash, untreated skin, fat, blood, and residual carcass) ranged from about 0.5% to 10% of that administered.
870.7600
Immunotoxicity (mouse)
48690105 (2011);
0, 100, 1,000, and 10,000 ppm
(0, 21, 200, 2,115 mg/kg/day [F])
Acceptable/Guideline
Systemic NOAEL (F) = 2,155 mg/kg/day.
Systemic LOAEL was no observed when tested above the limit dose.
Immunotoxicity NOAEL (F) = 200 mg/kg/day.
Immunotoxicity LOAEL = 2,155 mg/kg/day based on decreased anti-SRBC response.

Appendix B.  Physical/Chemical Properties

Table B.1.  Physicochemical Properties of Technical Grade Novaluron.
Parameter
Value
Reference
Melting range
176.5-178.0C
DP# 315780, 3-NOV-2005, S. Levy
pH
6.5

Density
1.56 g/cm[3] at 22C

Water solubility
3 μg/L at 20C

Solvent solubility (at 25C)
0.00839 g/L in n-heptane
1.88 g/L in xylene
14.5 g/L in methanol
198 g/L in acetone
113 g/L in ethyl acetate
0.98 g/L in n-octanol

Vapor pressure (mm Hg)
1.2 x 10[-7]

Dissociation constant, pKa
Not determined due to low water solubility.

Octanol/water partition coefficient, Log(KOW)
4.3 at 25C

UV/visible absorption spectrum
Molar absorption coefficients of at three maximum absorbances:
15,400 L/mol  cm at 253 nm (neutral)
9,780 L/mol  cm at 253 nm (acidic)
20,500 L/mol  cm at 263 nm (basic)

Henry's Constant at 25C
2 x 10[-5] atm::m[3]/mol
Product Chemistry, MRID 44961006

Appendix C.  Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These data, which include studies from the PHED 1.1, the AHETF database, and the ARTF database are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requirements.  For certain studies, the ethics review may have included review by the Human Studies Review Board.  Descriptions of data sources, as well as guidance on their use, can be found at the Agency website.


[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Page 18558]
[FR Doc No: 2019-08812]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1523]

Proposed Flood Hazard Determinations for Llano County, Texas and
Incorporated Areas

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is withdrawing
its proposed notice concerning proposed flood hazard determinations,
which may include the addition or modification of any Base Flood
Elevation, base flood depth, Special Flood Hazard Area boundary or zone
designation, or regulatory floodway (herein after referred to as
proposed flood hazard determinations) on the Flood Insurance Rate Maps
and, where applicable, in the supporting Flood Insurance Study reports
for Llano County, Texas and Incorporated Areas.

DATES: This withdrawal is effective May 1, 2019.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1523 to Rick Sacbibit, Chief, Engineering Services Branch, Federal
Insurance and Mitigation Administration, FEMA, 400 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 19, 2015, FEMA published a
proposed notice at 80 FR 50313, proposing flood hazard determinations
for Llano County, Texas and Incorporated Areas. FEMA is withdrawing the
proposed notice.

    Authority: 42 U.S.C. 4104; 44 CFR 67.4.

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2019-08812 Filed 4-30-19; 8:45 am]
 BILLING CODE 9110-12-P