[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Proposed Rules]
[Pages 24134-24138]
[FR Doc No: 2013-09540]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2005-0011; FRL-9805-7]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Koppers Co., Inc. (Florence
Plant) Superfund Site

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule; notice of intent.

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SUMMARY: The Environmental Protection Agency (EPA) Region 4 is issuing
a Notice of Intent to Delete the Koppers Co., Inc. (Florence Plant)
Superfund Site (Site) located in Florence, South Carolina, from the
National Priorities List (NPL) and requests public comments on this
proposed action. 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). The EPA and the
South Carolina Department of Health and Environmental Control (SCDHEC)
have determined that no further response activities under CERCLA are
appropriate. However, this deletion does not preclude future actions
under Superfund.

DATES: Comments must be received by May 24, 2013.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-2005-0011, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> Attention: Yvonne Jones.
     Mail: Yvonne Jones, Remedial Project Manager, Superfund
Remedial Section, Superfund Remedial Branch, Superfund Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
     Hand delivery: U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional EPA Office is open for business Monday
through Friday, 8:30 a.m. to 4:00 p.m., excluding Federal Holidays.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
2005-0011. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.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 email. 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 email comment
directly to EPA without going through http://www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.

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
where disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at:
    Regional Site Information Repository: U.S. EPA Record Center, Attn:
Ms. Anita Davis, Atlanta Federal Center, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. Hours of Operation (by appointment only):
8:30 a.m. to 4:00 p.m., Monday through Friday.
    Local Site Information Repository: Florence County Library, 509 S.
Dargan Street, Florence, SC 29506. Hours of Operation: 9:00 a.m.-8:30
p.m., Monday through Thursday. 9:00 a.m.-5:30 p.m., Friday through
Saturday. 2:00 p.m.-6:00 p.m., Sunday.

FOR FURTHER INFORMATION CONTACT: Yvonne Jones, Remedial Project
Manager, Superfund Remedial Section, Superfund Remedial Branch,
Superfund Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960,<PHONE_NUMBER>,
Electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Intended Site Deletion

I. Introduction

    EPA Region 4 announces its intent to delete the Koppers Co., Inc.
(Florence Plant) Superfund Site (Site) from the National Priorities
List (NPL) and requests public comment on this proposed action. The NPL
constitutes Appendix B of 40 CFR part 300 which is the National 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.
As a general matter, deletion of the Koppers Co., Inc. (Florence Plant)
Superfund Site from the NPL will clarify that the South Carolina
Department of Health and Environmental Control (SCDHEC), Bureau of Land
and Waste Management Resource Conservation and Recovery Act (``RCRA'')
Program will have primary responsibility for ensuring that the
hazardous wastes released at the Site are appropriately remediated.
Notwithstanding any such deletion of this Site from the NPL, in the
event that conditions at this Site warrant additional remedial
corrective action, this Site remains eligible for Fund-financed
remedial action. Pursuant to section 300.425(e)(3) of the NCP, 40 CFR
300.425(e)(3): ``All releases deleted from the NPL are eligible for
further Fund-financed remedial actions should future conditions warrant
such action. Whenever there is a significant release from a site
deleted from the NPL, the site shall be restored to the NPL without
application of the [Hazard Ranking System].'' Therefore, deletion of
this, or any other, site from the NPL does not preclude eligibility for
subsequent Fund-financed remedial action if future conditions warrant
such action.
    EPA will accept comments on the proposal to delete this site for
thirty (30) days after publication of this document in the Federal
Register.
    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 Koppers Co., Inc. (Florence
Plant) Superfund Site and demonstrates how it meets the deletion
criteria.

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 State, 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.
    Consistent with Section 300.425(e) of the NCP, 40 CFR 300.425(e),
EPA proposes deletion of the Koppers Co., Inc. (Florence Plant) Site
because, as explained further below, no further CERCLA response is
appropriate. This determination is based on a policy that EPA has
adopted for implementation of the NPL deletion criteria. This policy,
entitled ``The National Priorities List for Uncontrolled Hazardous
Waste Sites; Deletion Policy for Resource Conservation and Recovery Act
Facilities,'' was published in the Federal Register on March 20, 1995
(60 FR 14641). This policy sets forth the following criteria and their
general application for deleting RCRA facilities from the NPL:
    1. If evaluated under EPA's current RCRA/NPL deferral policy (which
refers to the policy in effect at the time the deletion decision is
made. As past Federal Register notices demonstrate, the RCRA/NCP
deferral policy has changed, and may continue to change based upon the
Agency's continued evaluation of how best to implement the statutory
authority of RCRA and CERCLA), the site would be eligible for deferral
from listing on the NPL;
    2. The CERCLA site is currently being addressed by RCRA corrective
action authorities under an existing enforceable order, or permit,
containing corrective action provisions;
    3. Response under RCRA is progressing adequately; and
    4. Deletion would not disrupt an ongoing CERCLA action.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) EPA consulted with the State of South Carolina before
developing this Notice of Intent to Delete.
    (2) The State of South Carolina, through SCDHEC, has concurred with
deletion of the Site from the NPL.
    (3) Concurrently with the publication of this Notice of Intent to
Delete in the Federal Register, a notice is being published in a major
local newspaper,

Florence Morning News. The newspaper notice announces the 30-day public
comment period concerning the Notice of Intent to Delete the site from
the NPL.
    (4) The EPA placed copies of documents supporting the proposed
deletion in the deletion docket and made these items available for
public inspection and copying at the Site information repositories
identified above.
    If adverse comments are received within the 30-day public comment
period on this document, EPA will evaluate and respond appropriately to
the comments before making a final decision to delete. If necessary,
EPA will prepare a Responsiveness Summary to address any significant
public comments received. After the public comment period, if EPA
determines it is still appropriate to delete the Site, the Regional
Administrator will publish a final Notice of Deletion in the Federal
Register. Public notices, public submissions and copies of the
Responsiveness Summary, if prepared, will be made available to
interested parties, and will be placed in the site information
repositories listed above.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion 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 site from the
NPL does not preclude eligibility for future response actions, should
future conditions warrant such actions.

IV. Basis for Site Deletion

    The following information provides EPA's rationale for deleting the
Site from the NPL.

A. Site Background

    The Koppers Co., Inc. (Florence Plant) Superfund Site (Facility)
(EPA CERCLIS Identification Number SCD003353026) is situated within an
approximate 200-acre tract located along North Koppers Street in
Florence, Florence County, South Carolina. The Facility is within an
area that is currently zoned industrial. The surrounding property is
used for a mixture of industrial, commercial, residential, and
transportation purposes. Private residential development borders the
northwest portion of the Facility. CSX Transportation owns and operates
a rail yard immediately south of the Facility. Areas to the north,
west, and east are relatively undeveloped. The Florence City-County
Airport is located south of the Facility across U.S. Highway 76/301.
    Constructed by the American Lumber and Treating Company, the
Facility has been in operation since 1946. Koppers Company, Inc. (KCI)
acquired the property in 1954. On December 29, 1988, KCI sold certain
of its business assets, including the Koppers Facility in Florence, as
well as the right to use the ``Koppers'' trade name, to Koppers
Industries, Inc., (now known as Koppers Inc. [KI]). Shortly thereafter,
in January 1989, KCI changed its name to ``Beazer Materials and
Services, Inc.,'' and then again changed its name, in April 1990, to
``Beazer East, Inc.'' (Beazer), its current name. KI currently owns the
Florence Wood Treating Facility. The Facility produces treated wood
products, including telephone poles, railroad ties, and fencing
materials for the utilities, railroad, and construction industries. The
primary wood preserving processes at the Facility are pressure
treatment with creosote, pressure treatment with pentachlorophenol
(PCP), and treatment with chromated-copper arsenate. A fire retardant
was previously (prior to 1988) used at the Facility. While the Facility
is currently owned and operated by KI, Beazer retains responsibility
for addressing certain environmental conditions caused by site
activities occurring before December 1988.
    Past practices at the Facility led to contamination of the soil,
sediment and groundwater. From the beginning of plant operations until
1979, creosote and PCP wastes at the Facility were stored in lagoons
located in the southwest corner of the Facility. In 1979, the use of
these lagoons was discontinued and the waste was land-farmed using a
process called spray irrigation. Prior to closure of the impoundments
and the spray irrigation field, wastewater flowed to three RCRA surface
impoundments. In 1980, a local resident notified SCDHEC that water from
his well had a creosote odor and a foul taste. Other residents of the
same area indicated similar taste and odor problems with their well
water. SCDHEC officials tested the well water in this area and
determined that it contained a significant level of creosote. In
response to the findings at the Facility, in October 1981, SCDHEC
issued Consent Order 81-56-W requiring KCI (now known as Beazer) to
proceed with studies to investigate groundwater conditions. Following
additional negotiations with SCDHEC, KCI (now known as Beazer) provided
public water to a neighborhood directly downgradient of the Facility by
funding water main extensions to the City of Florence water supply
system.
    From 1981 to the present, various investigations have been
performed at the Facility. Contaminants identified as being of concern
included PCP and other chlorinated phenols, polycyclic aromatic
hydrocarbons, copper, chromium, arsenic, and varied constituents of
creosote. As an interim measure, KCI constructed a groundwater
containment and recovery system at the Facility in August 1983. Due to
the presence of groundwater contamination, EPA also proposed the Site
on the NPL on September 8, 1983 (48 FR 40674) and finalized the Site on
the NPL on September 21, 1984 (49 FR 37070).
    Facility-wide investigations began in 1986, with EPA conducting the
RCRA Facility Assessment (RFA). The RFA identified thirty-three solid
waste management units (SWMUs) located throughout the Facility. To
simplify the response efforts, EPA, SCDHEC, and KCI (now known as
Beazer) agreed to implement a Facility-wide approach to address
historical releases from all former Facility sources and the thirty-
three SWMUs. To further address the Site, in February 3, 1988, EPA
issued a RCRA 3008(h) Consent Order (Docket Number 88-03-R) (RCRA CO)
requiring KCI (now known as Beazer) to perform a RCRA Facility
Investigation, Health and Ecological Risk Assessment and a Corrective
Measures Study (RFI/HERA/CMS) at the Facility.
    Concurrent with the RFI/HERA/CMS, in September 1995, SCDHEC issued
the Post-Closure Care Hazardous Waste Permit (Permit Number SCD 003 353
026) requiring KI and Beazer to conduct long-term monitoring and
maintenance activities necessary to protect the surrounding environment
and population from releases of hazardous constituents. The 1995 Post-
Closure Care Hazardous Waste Permit incorporates the RCRA CO .
    Pursuant to the RCRA CO and the 1995 Post-Closure Care Hazardous
Waste Permit, the CMS was finalized in August 2006. The findings of the
RFI/HERA/CMS identified potential risks from several areas at the
Facility and required corrective measures for the following media to
address those risks:
    On-site Facility Soils: Consists of potentially impacted surface
and subsurface soils within the property boundary of the Facility known
as the Inactive Non-Process Area (INPA). The INPA is located in a
wooded area immediately west of the active portion of the Facility
approximately 100 feet upstream of Outfall 001.
    Off-site Facility Soils: Consists of potentially impacted surface
soil within

the drainage ditch downgradient of Outfall 001. The Outfall 001 channel
area is located adjacent to the southwest corner of the Facility on
property owned by the CSX Corporation.
    Off-site Facility Sediment: Consists of potentially impacted stream
sediments in Two-Mile Creek, downgradient, and near the stormwater
detention pond. Two Mile Creek is located approximately 400 feet east
of the Site entrance.
    Groundwater: Consists of on-site Facility and off-site Facility
potentially impacted groundwater present within the upper unconfined
water-bearing zone.
    Taking into consideration regulatory requirements and the results
of the HERA, the following Corrective Action Objectives (CAOs) were
developed:
On-Site CAOs
     Soils--Mitigate unacceptable exposures to Site-related
constituents in soils for potential on-site Facility receptors.
     Groundwater--Mitigate potential future exposure to Site-
related groundwater constituents that exceed the safe drinking water
standards or acceptable risk levels.
     Manage dense non-aqueous phase liquid (DNAPL) in
accordance with EPA guidance on NAPLs.
Off-Site CAOs
     Surface Soils/Sediments--Mitigate unacceptable exposures
to Site-related constituents in surface soils and sediments for
potential off-site Facility receptors.
     Groundwater--Mitigate potential exposure to groundwater
constituents that exceed the safe drinking water standards or
acceptable risk levels. Manage DNAPL in accordance with EPA guidance on
NAPLs.
Additional CAOs
     Perform comprehensive corrective actions that integrate
the components of the Facility-wide and the regulated unit corrective
measures;
     Optimize long-term operations and maintenance (O&M); and
     Establish appropriate Institutional Controls to ensure
that future use is consistent with the CAOs.
    To achieve the CAOs, the facility completed the Corrective Measures
(CM) Work Plan in December 2011.The CM Work Plan presents the approach
to implement corrective measures at the following areas:
Inactive Non-Process Area (INPA)
    The area of excavation is approximately 5,200 square feet in size.
Six inches of soil, [approximately 100 cubic yards (cy)] will be
excavated from this area and placed in the on-site Corrective Action
Management Unit (CAMU). Imported fill material will be used to restore
the excavated area to original contours. Once the area has been
backfilled and graded, the area will be revegetated (seeded and
mulched). Mulching will consist of the placement of an erosion control
mulch blanket.
Channel Below Outfall 001
    The area of excavation is approximately 93,300 square feet. Two
feet of soil (approximately 6,900 cy) will be excavated from this area
and placed in the on-site CAMU. Imported fill material will be used to
restore the excavated area to near-original contours. Once the area has
been backfilled and graded, the area will be revegetated.
Two Localized and Nearby Segments Within Two Mile Creek
    Two areas totaling approximately 2,300 square feet will be
excavated within the streambed. One foot of soil (approximately 85 cy)
will be excavated from these areas, which are located on the north and
south sides of North Koppers Street, and placed in the on-site CAMU.
Imported fill material with a gradation similar to the existing channel
substrate will be used to restore the channel bottom. Once the
streambed has been reestablished, any areas adjacent to the creek that
were disturbed in order to provide access to the work areas will be
revegetated.
    The construction activities described in the CM Work Plan commenced
on April 23, 2012 and concluded in November 2012. A construction
completion report will be submitted to SCDHEC for review and approval.
In addition, beginning at the end of the fifth year of operation and
maintenance and monitoring, the system effectiveness will be evaluated
at 5-year intervals. In addition, a Corrective Measure completion
report will be submitted to SCDHEC when the corrective measure criteria
have been satisfied.
    The Facility is subject to environmental investigation and remedial
obligations pursuant to CERCLA, the requirements of the RCRA CO and the
corrective action requirements of the South Carolina Hazardous and
Solid Waste Amendments (HSWA) portion of the Post-Closure Care Permit.
EPA and SCDHEC have agreed that the RCRA Program has primary
responsibility for the ongoing activities at the Site.

B. Determination That the Site Meets the RCRA Deferral Criteria Set
Forth in EPA's March 20, 1995, Policy

    1. If evaluated under EPA's current RCRA/NPL deferral policy, the
Site would be eligible for deferral from listing on the NPL.
    At the time of the NPL listing, the Site posed a threat to human
health and the environment that was not being addressed under CERCLA,
or RCRA corrective action authorities. At that time, EPA determined
that the most expeditious way to address the contamination at the Site
was through the use of CERCLA authorities. Prior to the enactment of
the HSWA in 1984 only releases to groundwater from regulated units,
i.e. surface impoundments, waste piles, land treatment areas, and
landfills, were subject to corrective action requirements under RCRA.
The enactment of HSWA greatly expanded RCRA Subtitle C corrective
action authorities. As a result, KCI (now known as Beazer) and EPA on
February 3, 1988, entered into a RCRA CO and the order has been
addressing all of the contamination at the Site pursuant to section
3008(h) of RCRA. In addition, in September 1995, SCDHEC issued the
Post-Closure Care Hazardous Waste Permit requiring KI and Beazer to
conduct long-term monitoring and maintenance activities necessary to
protect the surrounding environment and population from releases of
hazardous constituents. This 1995 Post-Closure Care Hazardous Waste
Permit included post-closure care of the three former RCRA surface
impoundments and the thirty-three SWMUs. Furthermore, the 1995 Post-
Closure Care Hazardous Waste Permit incorporates the RCRA CO. KCI (now
known as Beazer) is fulfilling the conditions of the RCRA CO, and is in
compliance with the RCRA CO, and the Post-Closure Care Hazardous Waste
Permit. Consequently, if this Site was evaluated for NPL listing under
the current conditions, the Site would qualify for deferral to RCRA.
    2. The CERCLA Site is currently being addressed by RCRA corrective
action authorities under an existing enforceable order, and permit
containing corrective action provisions.
    As described previously, EPA and Beazer (previously known as KCI)
entered into a RCRA CO, pursuant to section 3008(h) of RCRA, on
February 3, 1988. Under the terms of that RCRA CO, Beazer (then known
as KCI) was required to complete an on-site and off-site investigation
of the nature and extent of the release of hazardous wastes from the
Site, and to conduct a study to evaluate various cleanup alternatives.

Beazer is fulfilling the conditions of the RCRA CO, and is currently in
compliance with the RCRA CO, and the Post-Closure Care Hazardous Waste
Permit.
    As also described previously, the 1988 RCRA CO will remain in
effect until such time when SCDHEC determines that the terms of this
order have been satisfied. All known contaminated media (groundwater
and soils), on and off-site, are being addressed through SCDHEC, and
EPA's exercise of its corrective action authorities pursuant to RCRA.
    3. Response under RCRA is progressing adequately.
    Corrective action is progressing satisfactorily under the RCRA CO,
as described above. Pursuant to the RCRA CO, Beazer has completed the
RFI, HERA, CMS, and is implementing the selected remedy at the
Facility. To prevent off-site migration of groundwater contamination,
and treat contaminated groundwater, Beazer (previously known as KCI)
constructed a groundwater containment and recovery system at the
Facility in August 1983. Operation and monitoring activities for the
groundwater containment and recovery system are ongoing. The
construction activities required to address the soil contamination
concluded in November 2012. Approximately 7000 cubic yards of soil have
been excavated from the Inactive Non-Process Area, and the Channel
below Outfall 001. This soil was placed in the on-site CAMU. Imported
fill material was used to restore the excavated areas to original
contours. In addition, completion of the construction activities
included excavation of two areas within Two Mile Creek. There has been
no history of protracted negotiations due to lack of cooperation.
    4. Deletion would not disrupt an ongoing CERCLA action.
    The RCRA Program is implementing the evaluation and remedy
selection activities normally covered during the Remedial
Investigation/Feasibility Study process under CERCLA, under the RCRA
CO. In a deferral memorandum dated October 26, 1987, EPA issued a
decision to transfer the Facility from Dual CERCLA/RCRA Coordination to
`Exclusive RCRA Lead and Responsibility'. There are no ongoing CERCLA
actions. In addition, EPA and SCDHEC have agreed that response
activities at the Facility will continue to proceed through RCRA.
    The EPA has received concurrence from SCDHEC. The EPA concludes
that this Site meets the criteria under the NPL deletion policy, and
announces its intention to delete the Site from the NPL. The EPA
believes it is appropriate to delete sites from the NPL based upon the
deferral policy to RCRA under these established circumstances. Deletion
of this Site from the NPL, to defer it to RCRA Subtitle C corrective
action authorities, avoids possible duplication of effort, and the need
for Beazer to follow more than one set of regulatory procedures.
Moreover, EPA and SCDHEC have determined that remedial actions
conducted at the Facility to date and scheduled in the future under
RCRA, have been and will remain protective of public health, and the
environment.

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.

    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.

    Dated: March 13, 2013.
Gwendolyn Keyes Fleming,
 Regional Administrator, Region 4.
[FR Doc. 2013-09540 Filed 4-23-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 164 (Wednesday, August 24, 2011)]
[Notices]
[Page 52958]
[FR Doc No: 2011-21630]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0587]

Draft Guidance for Industry on Neglected Tropical Diseases of the
Developing World: Developing Drugs for Treatment or Prevention;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Neglected
Tropical Diseases of the Developing World: Developing Drugs for
Treatment or Prevention.'' The purpose of this guidance is to assist
sponsors in the clinical development of drugs for the treatment or
prevention of neglected diseases of the developing world. Specifically,
this guidance addresses FDA's current thinking regarding the overall
drug development program for the treatment or prevention of neglected
tropical diseases (NTDs), including clinical trial designs and internal
review standards to support approval of drugs.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 22, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Neglected Tropical Diseases of the Developing World:
Developing Drugs for Treatment or Prevention.'' This guidance addresses
section 740 of the Agriculture, Rural Development, Food and Drug
Administration and Related Agencies Appropriations Act, 2010 (Pub. L.
111-80), dated October 21, 2009, that directed FDA to provide guidance
in the form of general recommendations and regulatory considerations
for drugs being developed for the treatment or prevention of NTDs.
NTDs, as defined in section 524(a)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360n(a)(3)), are infectious diseases that
generally are rare or absent in developed countries, but are often
widespread in developing countries. The availability of new drugs that
are safe and effective for treatment or prevention of NTDs could
provide public health benefit for overall global health.
    The purpose of this draft guidance is to provide recommendations to
sponsors and investigators who are involved in the development of drugs
for the treatment or prevention of NTDs. This guidance is intended to
clarify the regulatory requirements for drug approval in the United
States as well as the internal review standards for drugs for NTDs.
This guidance is directed at sponsors who lack general knowledge about
drug development issues. Potential sponsors should understand that: (1)
FDA will review and comment on clinical development programs for NTDs
under an investigational new drug application submission, regardless of
where the clinical development will take place; (2) FDA can approve a
drug for treatment of an NTD not endemic in the United States; (3) the
regulatory pathways and internal review standards for approval of drugs
for NTDs are the same as for approval of drugs for diseases endemic in
the United States; and (4) FDA is committed to exercising its
regulatory authorities to facilitate access to therapies that can help
reduce morbidity and mortality associated with NTDs.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21630 Filed 8-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Rules and Regulations]
[Pages 33197-33199]
[FR Doc No: 2013-12516]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0455; Directorate Identifier 2013-CE-013-AD;
Amendment 39-17461; AD 2013-11-01]
RIN 2120-AA64

Airworthiness Directives; Iniziative Industriali Italiane S.p.A.
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Iniziative Industriali Italiane S.p.A. Models Sky Arrow 650 TC, Sky
Arrow 650 TCN, Sky Arrow 650TCS, and Sky Arrow 650TCNS airplanes. This
AD results from mandatory continuing airworthiness information (MCAI)
issued by the aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as improper installation of the spherical bearing
on the central hinge lever and a crack on the weld length of the
horizontal tail/elevator plane hinge assembly. We are issuing this AD
to require actions to address the unsafe condition on these products.

DATES: This AD is effective June 19, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of June 19,
2013.
    We must receive comments on this AD by July 19, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Magnaghi
Aeronautica S.p.A., Via G. Ferraris, 76, 80142 Napoli, Italy;
telephone: + 39 081 5977 225; fax: + 39 081 5977 226; email:
<EMAIL_ADDRESS>Internet: www.magnaghiaeronautica.it.
You may review copies of the referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA, call
(816) 329-4148.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2013-0073-E, dated March 21, 2013 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    During an inspection on elevator/stabilizer hinges, improper
installation of the spherical bearing part number (P/N) SKF GE-10 on
the central hinge lever and a crack on the weld length of the
horizontal tail/elevator plane hinge assembly have been reported.
    This condition, if not detected and corrected, could lead to the
loss of the main elevator control.
    To address this potential unsafe condition, Magnaghi Aeronautica
issued Service Bulletin (SB-C) n. SB-005-2013-SKY ARROW to inspect
the affected areas of the pitch flight control system.
    For the reasons described above, this AD requires inspection of
the spherical bearing and the horizontal tail/elevator plane hinge
assembly to detect any crack, signs of corrosion or improper
installation, and accomplishment of the applicable corrective
actions.

The MCAI also requires sending a detailed report of any crack, signs of
corrosion, or improper installation found during the required
inspections to Magnaghi Aeronautica S.p.A.; requesting an FAA-approved
repair scheme; and incorporating the repair . You may obtain further
information by examining the MCAI in the AD docket.

Relevant Service Information

    Magnaghi Aeronautica SpA has issued Service Bulletin SB-C n. SB-
005-2013-SKY ARROW, Issue 1, dated March 13, 2013. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because This
condition, which, if not corrected, could lead to the loss of the main
elevator control and result in loss of control. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2013-0455; Directorate
Identifier 2013-CE-013-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD will affect 9 products of U.S. registry.
We also estimate that it will take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $1,530, or $170 per product.
    We are unable to estimate the costs to accomplish any necessary
repair that will be required based on the results of any required
inspection. Magnaghi Aeronautica S.p.A. will evaluate the damage of
each affected airplane and develop an appropriate repair scheme.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2013-11-01 Iniziative Industriali Italiane S.p.A.: Amendment 39-
17461; Docket No. FAA-2013-0455; Directorate Identifier 2013-CE-013-
AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective June 19,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Iniziative Industriali Italiane S.p.A. Models
Sky Arrow 650 TC, Sky Arrow 650 TCN, Sky Arrow 650TCS, and Sky Arrow
650TCNS airplanes, all serial numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as improper
installation of the spherical bearing on the central hinge lever and
a crack on the weld length of the horizontal tail/elevator plane
hinge assembly. We are issuing this AD to correct this condition,
which, if not corrected, could lead to the loss of the main elevator
control and could result in loss of control.

(f) Actions and Compliance

    Unless already done, do the following actions.
    (1) Before further flight after June 19, 2013 (the effective
date of this AD), and thereafter at intervals not to exceed 25 hours
time-in-service (TIS), perform detailed visual inspections of the
horizontal tail/elevator plane hinge assembly part number (P/N)
R26208/00 following paragraph 4. INSTRUCTIONS of Magnaghi
Aeronautica SpA Service Bulletin SB-C n. SB-005-2013-SKY ARROW,
Issue 1, dated March 13, 2013.
    (2) If during any inspection required by paragraph (f)(1) of
this AD, the spherical bearing is found partially or completely out
of its seat and/or signs of cracks or corrosion of the hinges, hinge
levers or hinge brackets are detected, before further flight send a
detailed report to Magnaghi Aeronautica S.p.A. following paragraph
4. INSTRUCTIONS of Magnaghi Aeronautica SpA Service Bulletin SB-C n.
SB-005-2013-SKY ARROW, Issue 1, dated March 13, 2013, to the address
specified in paragraph (i)(3) of this AD, requesting an FAA-approved
repair scheme and incorporating the repair.
    (3) As of June 19, 2013 (the effective date of this AD) do not
install any spherical bearing P/N SKF GE-10 or horizontal tail/
elevator plane hinge assembly P/N R26208/00 on any airplane, unless
it has passed the inspection following paragraph 4. INSTRUCTIONS of
Magnaghi Aeronautica SpA Service Bulletin SB-C n. SB-005-2013-SKY
ARROW, Issue 1, dated March 13, 2013.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs

for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Mike Kiesov, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2013-0073-E, dated March 21, 2013, for related information.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Magnaghi Aeronautica SpA Service Bulletin SB-C n. SB-005-
2013-SKY ARROW, Issue 1, dated March 13, 2013.
    (ii) Reserved.
    (3) For Iniziative Industriali Italiane S.p.A. service
information identified in this AD, contact Magnaghi Aeronautica
S.p.A., Via G. Ferraris, 76, 80142 Napoli, Italy; telephone: + 39
081 5977 225; fax: + 39 081 5977 226; email:
<EMAIL_ADDRESS>Internet:
www.magnaghiaeronautica.it.
    (4) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html

    Issued in Kansas City, Missouri, on May 20, 2013.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2013-12516 Filed 6-3-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Notices]
[Page 48139]
[FR Doc No: 2021-18478]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9058-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed August 16, 2021 10 a.m. EST Through August 23, 2021 10 a.m. EST
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20210122, Final, HHS, WV, Acquisition of Site for Development
of a Replacement Underground Safety Research Program Facility in Mace,
West Virginia, Review Period Ends: 09/27/2021, Contact: Sam Tarr 770-
488-8170.
EIS No. 20210123, Final, USACE, FL, Florida Keys Coastal Storm Risk
Management Study Final Integrated Feasibility Report and Environmental
Impact Statement, Review Period Ends: 09/27/2021, Contact: Kathy Perdue
757-201-7218.
EIS No. 20210124, Draft Supplement, FHWA, SC, Mark Clark Extension
Supplemental Environmental Impact Statement and Draft Section 4(f)
Evaluation, Comment Period Ends: 10/15/2021, Contact: J. Shane Belcher
803-253-3187.
EIS No. 20210125, Draft Supplement, NRC, VA, Generic Environmental
Impact Statement for License Renewal of Nuclear Plants, NUREG-1437,
Supplement 7, Second Renewal, North Anna Power Station, Comment Period
Ends: 10/12/2021, Contact: Tam Tran<PHONE_NUMBER>.
EIS No. 20210126, Draft, USFS, OR, Cliff Knox Project, Comment Period
Ends: 10/12/2021, Contact: Kate Cueno<PHONE_NUMBER>.
EIS No. 20210127, Draft, USACE, NJ, New Jersey Back Bays Draft
Integrated Feasibility Report and Tier 1 Environmental Impact
Statement, Comment Period Ends: 10/12/2021, Contact: Steven D. Allen
215-656-6559.

    Dated: August 23, 2021.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2021-18478 Filed 8-26-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 4, 2010 (Volume 75, Number 42)]
[Rules and Regulations]
[Page 9763-9767]
[DOCID:fr04mr10-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 61, 63, and 65

[Docket No.: FAA-2009-0923; Special Federal Aviation Regulation No.
100-2]
RIN 2120-AJ54

Relief for U.S. Military and Civilian Personnel Who Are Assigned
Outside the United States in Support of U.S. Armed Forces Operations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule; request for comments.

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

SUMMARY: The FAA is replacing Special Federal Aviation Regulation 100-1
(SFAR 100-1), with SFAR 100-2 that continues to allow Flight Standards
District Offices (FSDOs) to accept expired flight instructor
certificates and inspection authorizations for renewals from U.S.
military and civilian personnel (U.S. personnel) who are assigned
outside the United States in support of U.S. Armed Forces operations.
SFAR 100-2 also continues to allow FSDOs to accept expired airman
written test reports for certain practical tests from U.S. personnel
who are assigned outside the United States in support of U.S. Armed
Forces operations. This action is necessary to avoid penalizing U.S.
personnel who are unable to meet the regulatory time limits of their
flight instructor certificate, inspection authorization, or airman
written test report because they are serving outside the United States
in support of U.S. Armed Forces operations. The effect of this action
is to give U.S. personnel who are assigned outside the United States in
support of U.S. Armed Forces operations extra time to meet certain
eligibility requirements in the current rules.

DATES: This final rule is effective June 20, 2010.
    Submit comments on or before April 5, 2010.

ADDRESSES: You may send comments identified by Docket Number FAA-2009-
0923 using any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, U.S. Department
of Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
     Hand Delivery: Take comments to Docket Operations in Room
W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    For more information on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of this document.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
DocketsInfo.dot.gov.
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to Docket Operations in Room
W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: R. Lance Nuckolls, AFS-810, General
Aviation and Commercial Division, Flight Standards Service, Federal
Aviation Administration, 800 Independence Avenue, SW., Washington, DC
20591; telephone<PHONE_NUMBER>.
    For legal questions about this SFAR, contact: Michael Chase, AGC-
240, Office of Chief Counsel, Regulations Division, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone<PHONE_NUMBER>; e-mail to<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    Under 14 CFR 11.13 the FAA may issue a direct final rule with
request for comments which is a rule issued in final (with an effective
date) that invites public comment on the rule. The FAA is using the
direct final rule procedure because this rule is not controversial, not
expected to result in the receipt of an adverse comment, and a notice
of proposed rulemaking (NPRM) is not necessary. SFAR 100-2 will
continue to provide a limited amount of regulatory relief to certain
U.S. personnel who are assigned outside the United States in support of
U.S. Armed Forces operations. The FAA finds good cause for issuing this
direct final rule as an exception to notice and comment rulemaking
procedures. Unless a written adverse comment, or a written notice of
intent to submit an adverse comment, is received within the comment
period the regulation will become effective on June 20, 2010. In
previous issuances of this SFAR, we have received no comments.
    After the comment period closes, the FAA will publish a document in
the Federal Register indicating that no adverse comments were received
and confirming the date on which the SFAR will become effective. In the
event that the FAA receives a timely adverse comment, or a written
notice of intent to submit such a comment, the FAA will withdraw the
direct final rule. An NPRM may be published with a new comment period.

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. We also
invite comments relating to the economic, environmental, energy, or
federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, please send only one copy of written comments, or
if you are filing comments electronically, please submit your comments
only one time.
    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Background

    Currently, the U.S. Armed Forces are engaged in activities that
have resulted in overseas assignments for both military and civilian
personnel. Because of the unexpected duration of these assignments, the
FAA has determined that the flight instructor certificates, inspection
authorizations, and airman written test reports held by some U.S.
military and civilian personnel may expire before they return to the
United States. If so, these individuals would have to reestablish their
qualifications. We believe it is unfair to penalize these military and
civilian personnel in this manner. Therefore, the FAA has determined
that we should provide relief to these U.S. personnel who are unable to
comply with some of the regulatory time constraints as a result of
their assignment outside the United States in support of U.S. Armed
Forces operations.

Previous Regulatory Action

    After the terrorist attacks of September 11, 2001, many U.S.
military and civilian personnel were assigned outside the United States
in support of Operation Enduring Freedom. For this reason, we adopted
SFAR 96 to provide relief to a narrow range of individuals in a narrow
set of circumstances. (67 FR 30524, May 6, 2002). As a result of the
continuing conflicts, the FAA superseded SFAR 96 with SFAR 100 (68 FR
36902, June 20, 2003) that applied to all military and civilian
personnel assigned overseas in support of any and all U.S. Armed Forces
operations. Additionally, the FAA further extended SFAR 100 with the
issuance of SFAR 100-1 (70 FR 37946-37949, June 30, 2005) with an
expiration date of June 20, 2010. Most of these U.S. military and
civilian personnel are or will be located at military bases that are
away from their normal training or work environment. There are no FAA
aviation safety inspectors, designated examiners, or FAA facilities
readily available in the areas where these U.S. military and civilian
personnel are assigned.
    SFAR 100-2 replaces SFAR 100-1. SFAR 100-2 is being issued without
an expiration date and will remain in effect until further notice. This
ensures these U.S. personnel assigned outside of the United States, who
continue to preserve, protect and defend the American public, can
obtain additional time for renewal of their flight instructor
certificates, inspection authorizations, and airman written test
reports.

Who is affected by this SFAR?

    To be eligible for the relief provided by this SFAR, a person must
meet two criteria--one related to the person's assignment and the
second related to the expiration of the person's certificate,
authorization, or test report.
    Assignment. The person must have served in a civilian or military
capacity outside the United States in support of U.S. Armed Forces
operations some time on or after September 11, 2001. The term ``United
States'' is defined under 14 CFR 1.1 and means ``the States, the
District of Columbia, Puerto Rico, and the possessions, including the
territorial waters and the airspace of those areas.'' ``In support of
U.S. Armed Forces operations'' means an assignment that supports
operations being conducted by our U.S. Army, Navy, Air Force, Marine
Corps, and Coast Guard, including their regular and reserve components.
Members serving without component status are also covered. A person
seeking relief under this SFAR must be able to show that he or she had
an assignment as described above by providing appropriate documentation
that is described below.
    Expiration. The person's flight instructor certificate, inspection
authorization, or airman written test report must have expired some
time on or after September 11, 2001.

Renewing a Flight Instructor Certificate

    The FAA regulations governing flight instructor certificates
provide that they expire 24 calendar months after the month of
issuance. The regulations also provide that a flight instructor may
renew his or her certificate before it expires, but if it expires, the
flight instructor must get a new certificate. If you are interested in
the details of how to get or renew a flight instructor certificate,
please see 14 CFR 61.197 and 61.199.
    This SFAR changes the existing regulations for a certain class of
individuals by allowing FAA Flight Standards District Offices to accept
for a limited amount of time an expired flight instructor certificate
for the purpose of renewing the certificate. Therefore, a person who
can show the kind of evidence required by this SFAR (described below)
can apply for renewal of a flight instructor certificate under 14 CFR
61.197. A person cannot exercise the privileges of a flight instructor
certificate if it has expired, but the person can renew the flight
instructor certificate under the limited circumstances described in
this SFAR.

Airman Written Test Reports of Parts 61, 63, and 65

    Generally, FAA regulations give airmen a limited amount of time to
take a practical test after passing a knowledge test. For example, 14
CFR 61.39(a)(1) gives a person 24 calendar months. This SFAR permits an
extension of the expiration date of the airman written test reports of
parts 61, 63, and 65. The extension can be for up to six calendar
months after returning to the United States or termination of SFAR 100-
2, whichever date is earlier.

Renewing an Inspection Authorization

    Under 14 CFR 65.92, an inspection authorization expires on March 31
of each year. Under 14 CFR 65.93, a person can renew an inspection
authorization for an additional 12 calendar months by presenting
certain evidence to the FAA during the month of March. This SFAR
changes the existing regulations for individuals eligible under this
SFAR by allowing FAA Flight Standards District Offices to accept for a
limited amount of time an expired inspection authorization for the
purpose of renewing the authorization. Therefore, a person who can show
the kind of evidence required by this SFAR (described below) can apply
for renewal of an inspection authorization under 14 CFR 65.93. If an
inspection authorization expires, the person may not exercise the
privileges of the authorization until that person renews the
authorization. In this case, to meet the renewal requirements the
person must attend a refresher course (see Sec.  65.93(a)(4)) or submit
to an oral test (See Sec.  65.93(a)(5)) within 6 calendar months after
returning to the United States from an assignment outside the United
States in support of U.S. Armed Forces operations.

Evidence of an Assignment Outside the United States in Support of U.S.
Armed Forces Operations

    A person must show one of the following kinds of evidence to
establish that the person is eligible for the relief provided by this
SFAR:
    1. An official U.S. Government notification of personnel action, or
equivalent document, showing the person was a U.S. civilian on official
duty for the U.S. Government and was assigned outside the United States
in support of U.S. Armed Forces operations at some time between
September 11, 2001 to termination of SFAR 100-2;
    2. An official military order that shows the person was assigned to
military duty outside the United States in support of U.S. Armed Forces
operations at some time after September 11, 2001 to termination of SFAR
100-2; or
    3. A letter from the person's military commander or civilian
supervisor providing the dates during which the person served outside
the United States in support of U.S. Armed Forces operations at some
time between September 11, 2001 to termination of SFAR 100-2.

International Compatibility

    In keeping with U.S obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. We have determined that there
is no new information collection requirement associated with this final
rule.

Regulatory Evaluation, Regulatory Flexibility Determination,
International Trade Impact Assessment, and Unfunded Mandates Assessment

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs each Federal agency to
propose or adopt a regulation only after a reasoned determination that
the benefits of the intended regulation justify its costs. Second, the
Regulatory Flexibility Act of 1980 requires agencies to analyze the
economic impact of regulatory changes on small entities. Third, the
Trade Agreements Act (19 U.S.C. 2531-2533) prohibits agencies from
setting standards that create unnecessary obstacles to the foreign
commerce of the United States. In developing U.S. standards, this Trade
Act also requires agencies to consider international standards and,
where appropriate, use them as the basis of U.S. standards. And fourth,
the Unfunded Mandates Reform Act of 1995 requires agencies to prepare a
written assessment of the costs, benefits and other effects of proposed
or final rules that include a Federal mandate likely to result in the
expenditure by State, local or tribal governments, in the aggregate, or
by the private sector, of $100 million or more annually (adjusted for
inflation.)
    The Department of Transportation Order DOT 2100.5 prescribes
policies and procedures for simplification, analysis, and review of
regulations. If the expected cost impact is so minimal that a proposal
does not warrant a full evaluation, this order permits a statement to
that effect and the basis for it to be included in the preamble and a
full regulatory evaluation need not be prepared. Such a determination
has been made for this rule. The reasoning for that determination
follows.
    The FAA has determined that the expected economic impact of this
final rule is so minimal that it does not need a full regulatory
evaluation. This action imposes no costs on operators subject to this
rule; however, it does provide some unquantifiable benefits to some who
would avoid the costs of having to reestablish expired credentials. The
expected outcome will have a minimal impact with positive net benefits,
and a regulatory evaluation was not prepared.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) of 1980, 5 U.S.C. 601-612,
directs the FAA to fit regulatory requirements to the scale of the
business, organizations, and governmental jurisdictions subject to the
regulation. We are required to determine whether a proposed or final
action will have a ``significant economic impact on a substantial
number of small entities'' as defined in the Act. If we find that the
action will have such impacts, we must do a ``regulatory flexibility
analysis.''
    This SFAR replaces Special Federal Aviation Regulation 100-1 (SFAR
100-1), with SFAR 100-2 that continues to allow Flight Standards
District Offices (FSDOs) to accept expired flight instructor
certificates and inspection authorizations for renewals from U.S.
military and civilian personnel (U.S. personnel) who are assigned
outside the United States in support of U.S. Armed Forces operations.
SFAR 100-2 also continues to allow FSDOs to accept expired airman
written test reports for certain practical tests from U.S. personnel
who are assigned outside the United States in support of U.S. Armed
Forces operations. Its economic impact is minimal. Therefore, we
certify that this action will not have a significant economic impact on
a substantial number of small entities.

International Trade Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create

unnecessary obstacles to the foreign commerce of the United States.
Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such as protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA notes
that this rule uses international standards as its basis and does not
create unnecessary obstacles to the foreign commerce of the United
States.

Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action''. The FAA currently
uses an inflation-adjusted value of $136.1 million in lieu of $100
million.
    This final rule does not contain such a mandate. Therefore, the
requirements of Title II of the Act do not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this SFAR under the principles and criteria of
Executive Order 13132, Federalism. We determined that this action will
not have a substantial direct effect on the States, or the relationship
between the Federal Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Therefore, it does not have federalism implications.

Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f and involves no extraordinary
circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or
Use

    The FAA has analyzed this SFAR under Executive Order 13211, Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We have determined that it is not
a ``significant energy action'' under the executive order because it is
not a ``significant regulatory action'' under Executive Order 12866,
and it is not likely to have a significant adverse effect on the
supply, distribution, or use of energy.

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking portal (http://
www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at--http://
www.faa.gov/regulations_policies.
    3. Accessing the Government Printing Office's Web page at--http://
www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment or docket number of this rulemaking.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://DocketsInfo.dot.gov.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. Therefore, any small entity that has a question regarding
this document may contact their local FAA official, or the person
listed under FOR FURTHER INFORMATION CONTACT. You can find out more
about SBREFA on the Internet at our site--
    http://www.faa.gov/regulations_policies/rulemaking/sbre_act.

List of Subjects

14 CFR Part 61

    Aircraft, Aircraft pilots, Airmen, Airplanes, Air safety, Air
transportation, Aviation safety, Balloons, Helicopters, Rotorcraft,
Students.

14 CFR Part 63

    Air safety, Air transportation, Airman, Aviation safety, Safety,
Transportation.

14 CFR Part 65

    Airman, Aviation safety, Air transportation, Aircraft.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends parts 61, 63, and 65 of Title 14 Code of Federal Regulations as
follows:

PART 61--CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND
INSTRUCTORS

0
1. The authority citation for part 61 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-
44711, 45102-45103, 45301-45302.

SFAR 100-1 [Removed]

0
2. Remove SFAR 100-1 from parts 61, 63 and 65.

0
3. Add Special Federal Aviation Regulation (SFAR) No. 100-2 to parts
61, 63 and 65 to read as follows: [The full text of the SFAR will
appear in part 61]

SFAR No. 100-2--Relief for U.S. Military and Civilian Personnel Who are
Assigned Outside the United States in Support of U.S. Armed Forces
Operations

    1. Applicability. Flight Standards District Offices are authorized
to accept from an eligible person, as described in paragraph 2 of this
SFAR, the following:
    (a) An expired flight instructor certificate to show eligibility
for renewal of a flight instructor certificate under Sec.  61.197, or
an expired written test report to show eligibility under part 61 to
take a practical test;
    (b) An expired written test report to show eligibility under
Sec. Sec.  63.33 and 63.57 to take a practical test; and
    (c) An expired written test report to show eligibility to take a
practical test required under part 65 or an expired inspection
authorization to show eligibility for renewal under Sec.  65.93.
    2. Eligibility. A person is eligible for the relief described in
paragraph 1 of this SFAR if:
    (a) The person served in a U.S. military or civilian capacity
outside the

United States in support of the U.S. Armed Forces' operation during
some period of time from September 11, 2001, to termination of SFAR
100-2;
    (b) The person's flight instructor certificate, airman written test
report, or inspection authorization expired some time between September
11, 2001, and 6 calendar months after returning to the United States or
termination of SFAR 100-2, whichever is earlier; and
    (c) The person complies with Sec.  61.197 or Sec.  65.93 of this
chapter, as appropriate, or completes the appropriate practical test
within 6 calendar months after returning to the United States, or upon
termination of SFAR 100-2, whichever is earlier.
    3. Required documents. The person must send the Airman Certificate
and/or Rating Application (FAA Form 8710-1) to the appropriate Flight
Standards District Office. The person must include with the application
one of the following documents, which must show the date of assignment
outside the United States and the date of return to the United States:
    (a) An official U.S. Government notification of personnel action,
or equivalent document, showing the person was a civilian on official
duty for the U.S. Government outside the United States and was assigned
to a U.S. Armed Forces' operation some time between September 11, 2001,
to termination of SFAR 100-2;
    (b) Military orders showing the person was assigned to duty outside
the United States and was assigned to a U.S. Armed Forces' operation
some time between September 11, 2001, to termination of SFAR 100-2 ; or
    (c) A letter from the person's military commander or civilian
supervisor providing the dates during which the person served outside
the United States and was assigned to a U.S. Armed Forces' operation
some time between September 11, 2001, to termination of SFAR 100-2.
    4. Expiration date. This Special Federal Aviation Regulation No.
100-2 is effective until further notice.

PART 63--CERTIFICATION: FLIGHT CREWMEMBERS OTHER THAN PILOTS

0
4. The authority citation for part 63 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-
44711, 45102-45103, 45301-45302.

PART 65--CERTIFICATION: AIRMEN OTHER THAN FLIGHT CREWMEMBERS

0
5. The authority citation for part 65 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-
44711, 45102-45103, 45301-45302.

    Issued in Washington, DC, on February 22, 2010.
J. Randolph Babbitt,
Administrator.
[FR Doc. 2010-4580 Filed 3-3-10; 8:45 am]
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[Federal Register: July 23, 2008 (Volume 73, Number 142)]
[Notices]
[Page 42819]
[DOCID:fr23jy08-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Peripheral and Central Nervous System Drugs Advisory Committee;
Notice of Postponement of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is postponing the
meeting of the Peripheral and Central Nervous Drugs Advisory Committee
scheduled for August 6 and 7, 2008. This meeting was announced in the
Federal Register of July 8, 2008 (73 FR 39017). The postponement is due
to difficulties in empanelling the necessary experts due to both
scheduling conflicts and conflict-of-interest issues.

FOR FURTHER INFORMATION CONTACT: Diem-Kieu Ngo, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512543. Please call the Information Line for up-to-date information
on this meeting.

    Dated: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-16814 Filed 7-22-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: April 24, 2007 (Volume 72, Number 78)]
[Proposed Rules]
[Page 20302-20304]
[DOCID:fr24ap07-17]

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

40 CFR Part 63

[EPA-HQ-OAR-2002-0093; FRL-8304-3]
RIN 2060-AN10

National Emission Standards for Hazardous Air Pollutants: Surface
Coating of Automobiles and Light-Duty Trucks; National Emission
Standards for Hazardous Air Pollutants for Surface Coating of Plastic
Parts and Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend the National Emission Standards for
Hazardous Air Pollutants: Surface Coating of Automobiles and Light-Duty
Trucks (Automobiles and Light-Duty Trucks NESHAP) to clarify the
interaction between the Automobiles and Light-Duty Trucks NESHAP and
the National Emission Standards for Hazardous Air Pollutants for
Surface Coating of Plastic Parts and Products (Plastic Parts NESHAP),
to clarify the meaning of certain regulatory provisions, and to correct
certain errors identified in the regulatory text. EPA is also proposing
to amend the Plastic Parts NESHAP to clarify that screen printing is
not subject to that rule.

DATES: Comments. Written comments must be received on or before May 24,
2007 unless a public hearing is requested by May 4, 2007. If a public
hearing is requested, written comments must be received on or before
June 8, 2007.
    Public Hearing. If anyone contacts EPA requesting to speak at a
public hearing, a public hearing will be held on May 9, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2002-0093, by mail to Air and Radiation Docket (6102T), 1200
Pennsylvania Avenue, NW., Washington, DC 20460. Please include a total
of two copies. Comments may also be submitted electronically or through
hand delivery/courier by following the detailed instructions in the
ADDRESSES section of the direct final rule located in the rules section
of this Federal Register.
    We request that you also send a separate copy of each comment to
the contact person listed below (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: For further information contact Mr.
David Salman, EPA, Office of Air Quality Planning and Standards, Sector
Policies and Programs Division, Coatings and Chemicals Group (E143-01),
Research Triangle Park, NC 27711; telephone number<PHONE_NUMBER>; fax
number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Why is EPA issuing this proposed rule? This document proposes to
take action on the Automobiles and Light-Duty Trucks NESHAP and the
Plastic Parts NESHAP. We are proposing to amend the Automobiles and
Light-Duty Trucks NESHAP to clarify the interaction between the
Automobiles and Light-Duty Trucks NESHAP and the Plastic Parts NESHAP,
to clarify the meaning of certain regulatory provisions, and to correct
certain errors identified in the regulatory text. We are also proposing
to amend the Plastic Parts NESHAP to clarify that screen printing is
not subject to that rule. We have published a parallel direct final
rule in the ``Rules and Regulations'' section of this Federal Register
because we view this as a noncontroversial action and anticipate no
adverse comment. We have explained our reasons for this action in the
preamble to the direct final rule.
    If we receive no adverse comment and no request for a public
hearing on the parallel direct final rule, we will not take further
action on this proposed rule. If we receive adverse comment on the
direct final rule or a request for a public hearing, we will withdraw
that rule and it will not take effect. In this instance, we would
address all public comments in any subsequent final rule based on this
proposed rule.
    If we receive adverse comment on a distinct provision of the direct
final rule, we will publish a timely withdrawal in the Federal Register
indicating which provisions we are withdrawing. The provisions that are
not withdrawn will become effective on the date set out in the direct
final rule, notwithstanding adverse comment on any other provision.
    We do not intend to institute a second comment period on this
action. Any parties interested in commenting must do so at this time.
For further information, please see the information provided in the
ADDRESSES section of this document.
    Regulated Entities. Categories and entities potentially regulated
by this action include:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                Category                    NAICS\*\ code                            Examples of potentially regulated entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Industry................................            336111  Automobile manufacturing.
                                                    336112  Light truck and utility vehicle manufacturing.
                                                    336211  Motor vehicle body manufacturing.
                                                    336120  Heavy duty truck manufacturing.
                                                    323113  Commercial screen printing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\North American Industry Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. To determine whether your facility is regulated by this action,
you should examine the applicability criteria of the rule. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.
    Public Hearing. Persons interested in presenting oral testimony or
inquiring as to whether a hearing is to be held should contact Mr.
David Salman, EPA, Office of Air Quality Planning and Standards, Sector
Policies and Programs Division, Coatings and Chemicals Group (E143-01),
Research Triangle Park, NC 27711, telephone number<PHONE_NUMBER>, e-
mail address<EMAIL_ADDRESS>at least 2 days in advance of the
potential date of the public hearing. Persons interested in attending
the public hearing must also call Mr. Salman to verify the time, date,
and location of the hearing. The public hearing will provide interested
parties the opportunity to present data, views, or arguments concerning
these proposed emission standards.
    Worldwide Web (WWW). In addition to being available in the docket,
an electronic copy of today's proposal will also be available through
the http://WWW. Following the Administrator's signature, a copy of this action

will be posted on EPA's Technology Transfer Network (TTN) policy and
guidance page for newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg/.
 The TTN at EPA's Web site provides information

and technology exchange in various areas of air pollution control.

Statutory and Executive Order Reviews

    For a complete discussion of all of the administrative requirements
applicable to this action, see the direct final rule in the Rules and
Regulations section of today's Federal Register.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any

other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions.
    For purposes of assessing the impact of today's proposed rule
amendments on small entities, a small entity is defined as: (1) A small
business according to Small Business Administration size standards for
companies identified by NAICS codes 336111 (automobile manufacturing)
and 336112 (light truck and utility vehicle manufacturing) with 1,000
or fewer employees or by NAICS code 323113 (commercial screen printing)
with 500 or fewer employees; (2) a small governmental jurisdiction that
is a government or a city, county, town, school district or special
district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
Based on the above definition, there are no small entities presently
engaged in automobile and light-duty truck surface coating. While there
are small entities presently engaged in commercial screen printing, the
proposed rule amendments would not impose any requirements on
commercial screen printers.
    After considering the economic impacts of today's proposed rule
amendments on small entities, I certify that this action will not have
a significant economic impact on a substantial number of small
entities. This is based on the observation that the proposed rule
affects no small entities since none are engaged in the surface coating
of automobiles and light-duty trucks, and no requirements are imposed
on commercial screen printers. We continue to be interested in the
potential impacts of the proposed rule amendments on small entities and
welcome comments on issues related to such impacts.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.

    Dated: April 18, 2007.
Stephen L. Johnson,
Administrator.
[FR Doc. E7-7758 Filed 4-23-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: November 9, 2009 (Volume 74, Number 215)]
[Notices]
[Page 57669]
[DOCID:fr09no09-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-8-000]

Town of Edinburg, Indiana, Complainant, v. Indiana Michigan Power
Agency, Respondent; Notice of Complaint

November 2, 2009.
    Take notice that on October 29, 2009, pursuant to sections 206 and
211A of the Federal Power Act, 16 U.S.C. 824e, and 824j-i, and Rule 206
of the Commission's regulations, 18 CFR 385.206, the Town of Edinburgh,
(Complainant), filed a formal complaint against the Indiana Municipal
Power Agency (Respondent) alleging that the Respondent is in violation
of section 211A of the Federal Power Act for failure to charge
Complainant a comparable transmission rate and resulting discriminatory
overcharges against Complainant of at least $1.98 million for the
period 2003 through 2009.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 18, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-26887 Filed 11-6-09; 8:45 am]

BILLING CODE 6717-01-P