[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Rules and Regulations]
[Pages 10391-10395]
[FR Doc No: 2014-03329]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-HQ-OAR-2014-0032; FRL-9906-80-OAR]

Finding of Failure To Submit State Implementation Plans Required
for the 2008 Lead National Ambient Air Quality Standards (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action finding that the Commonwealth of Pennsylvania has not submitted
state implementation plans (SIPs) for three nonattainment areas in
Berks and Beaver Counties to meet the requirements of the Clean Air Act
(CAA) for attaining the 2008 Lead National Ambient Air Quality
Standards (NAAQS). Pennsylvania has not yet submitted SIPs for three
nonattainment areas--the Lyons and North Reading nonattainment areas in
Berks County and the Lower Beaver Valley nonattainment area in Beaver
County--that demonstrate how each nonattainment area would attain the
2008 Lead NAAQS as expeditiously as practicable. These plans were due
by June 30, 2012. If Pennsylvania has not submitted and the EPA has not
approved the required attainment plans for its nonattainment areas by
no later than 2 years after the effective date of this finding, the EPA
must promulgate a federal implementation plan (FIP) for the affected
nonattainment area. In addition, the CAA provides for the imposition of
sanctions if the state does not submit the required attainment SIP
within specific timeframes.

DATES: Effective Date: This action is effective on February 25, 2014.
Under the Administrative Procedure Act (APA), 5 U.S.C. 553(d)(3), an
agency rulemaking may take effect before 30 days after the date of
publication in the Federal Register if the agency has good cause to
specify an earlier effective date. This action concerns SIP submissions
that were due by June 30, 2012. In addition, this action simply starts
a ``clock'' that will not result in sanctions for 18 months, and which
Pennsylvania may avoid by submitting complete SIPs to the EPA. The EPA
finds these reasons provide good cause for an immediate effective date.

FOR FURTHER INFORMATION CONTACT: General questions concerning this rule
should be addressed to Ms. Mia South, Office of Air Quality Planning
and Standards, Air Quality Policy Division, U.S. Environmental
Protection Agency, Mail Code: C504-2, 109 T.W. Alexander Drive,
Research Triangle Park, NC 27711; telephone<PHONE_NUMBER>. For
questions related to Pennsylvania, please contact the EPA's Region 3,
Cristina Fernandez, Associate Director, Office of Air Program Planning
(3AP30), Air Protection Division, U.S. Environmental Protection Agency,
Region 3, 1650 Arch Street, Philadelphia, PA 19103-2023; telephone
(215) 814-2178.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Notice-and-Comment Under the APA

    Section 553 of the APA, 5 U.S.C. 553(b)(B), provides that, when an
agency for good cause finds that notice and public procedure are
impracticable, unnecessary or contrary to the public interest, the
agency may issue a rule without providing notice and an opportunity for
public comment. The EPA has determined that there is good cause for
making this rule final without prior proposal and opportunity for
comment because no significant EPA judgment is involved in making a
finding of failure to submit SIPs, or elements of SIPs, required by the
CAA, where states have made no submissions to meet the requirement.
Thus, notice and public procedure are unnecessary. The EPA finds that
this constitutes good cause under 5 U.S.C. 553(b)(B). As the EPA has
explained in prior rulemakings, see e.g., 58 FR 51270, 51272, n.7
(October 1, 1993), under section 110(k)(1), the CAA provides the EPA
with a 60-day period after receiving a submittal from a state in which
to determine whether a submittal is complete. If no plan is submitted,
the CAA requires the EPA to make a determination to that effect within
6 months of the deadline for submittal. Since Congress provided the EPA
only 60 days to determine whether a state that has made some submittal
failed to submit a complete SIP, and it is generally impossible to
assess a submittal for completeness and then provide notice-and-comment
before making a final determination within 60 days, the EPA believes
that Congress clearly intended that the EPA should not go through
notice-and-comment rulemaking prior to making findings of failure to
submit a complete SIP when the state has made some submittal. In this
case, the EPA is making findings that the state has made no submittal,
and therefore no complete submittal, more than 6 months after the
deadline for submittal, but the EPA similarly

believes that Congress did not intend that the EPA go through notice-
and-comment rulemaking in this case.

B. How can I get copies of this document and other related information?

    The EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2014-0032. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the EPA Docket Center, EPA/DC, William Jefferson Clinton
Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER> and the telephone number for the Office
of Air and Radiation Docket and Information Center is<PHONE_NUMBER>.

C. How is this preamble organized?

Table of Contents

I. General Information
    A. Notice-and-Comment Under the APA
    B. How can I get copies of this document and other related
information?
    C. How is the preamble organized?
II. Background and Overview
    A. Statutory Requirements
    B. The EPA's Clean Data Policy
III. Findings of Failure To Submit for Pennsylvania for Attainment
SIPs for the 2008 Lead NAAQS
IV. This Action
V. Statutory and Executive Order (EO) Reviews
    A. Executive Order 12866: Regulatory Planning and Executive
Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act of 1995 (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority and Low Income Populations
    K. Congressional Review Act
    L. Judicial Review

II. Background and Overview

    Subpart 5, part D of title I of the CAA requires states with areas
that are designated nonattainment for the 2008 Lead NAAQS to develop a
SIP providing how the state will attain the air standards. Section 172
of the CAA specifies the required elements of a SIP for an area
designated nonattainment for the 2008 Lead NAAQS. These requirements
include, but are not limited to, an attainment demonstration,
reasonably available control measures (RACM) and reasonably available
control technology (RACT), annual emissions reductions as necessary to
ensure reasonable further progress (RFP) and contingency measures. Most
states with lead nonattainment areas designated in 2010 have submitted
SIPs addressing these requirements as required under the CAA. However,
one state, Pennsylvania, has not yet submitted SIPs for three
nonattainment areas--the Lyons and North Reading nonattainment areas in
Berks County and the Lower Beaver Valley nonattainment area in Beaver
County. These SIPs were due on June 30, 2012. By this action, the EPA
is making a finding that Pennsylvania has failed to submit the required
complete SIPs for these three nonattainment areas.

A. Statutory Requirements

    On October 15, 2008, the EPA promulgated revised NAAQS for lead.\1\
The agency revised the level of the primary lead standard from 1.5
micrograms per cubic meter ([mu]g/m\3\) to 0.15 [mu]g/m\3\, and also
revised the averaging time and form of the lead standards. The
calculation method for the averaging time is a ``rolling'' 3-month
period with a maximum (not-to-be-exceeded) form, evaluated over a 3-
year period. The EPA also revised the secondary NAAQS to make it
identical to the revised primary standard. In conjunction with
strengthening the lead standards, the EPA improved the existing lead
monitoring network by requiring monitors to be placed in areas with
sources, such as certain industrial facilities, and at other sites.
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    \1\ See 73 FR 66964, November 12, 2008, National Ambient Air
Quality Standards for Lead, Final Rule.
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    On November 16, 2010, the EPA identified or ``designated'' 16
areas, consisting of 17 partial counties, as ``nonattainment areas''
not meeting the 2008 NAAQS for lead. In this first round, the EPA
designated areas nonattainment based on 2007-2009 air quality
monitoring data. These designation actions were effective on December
31, 2010. On November 8, 2011, the EPA completed a second round of
designations, based on monitoring data from 2008-2010, including
monitors newly established under the 2008 Lead NAAQS Rule. In this
second round, the EPA designated five areas, including five partial
counties, as nonattainment and designated the remaining areas in the
country as attainment/unclassifiable or unclassifiable for the 2008
Lead NAAQS. These designation actions were effective on December 31,
2011. For the full listing of areas designated nonattainment for the
2008 Lead NAAQS (15 states, 21 nonattainment areas and 22 partial
counties) see http://www.epa.gov/leaddesignations/2008standards/documents/2011-11-08/LeadNAAreaList.pdf.
    The three areas in Pennsylvania were designated nonattainment in
the first round, effective December 31, 2010. In accordance with the
CAA, attainment SIPs for these areas were required to be submitted no
later than June 30, 2012. As explained in further detail in the 2008
Lead NAAQS Rule, the key required elements of the attainment SIP
include the attainment demonstration, RACM/RACT, RFP and contingency
measures. The attainment demonstration provides details on how a
nonattainment area will reduce pollution and provides a plan for the
area to meet the lead NAAQS. Under subpart 5 part D of title I of the
CAA, an attainment demonstration for these areas is required to show
how the nonattainment area will attain the 2008 Lead NAAQS as
expeditiously as practicable, but no later than 5 years after the
effective date of designation, or December 31, 2015, for the areas
designated in the first round for which Pennsylvania failed to submit
an attainment SIP. The attainment demonstration takes into account
projected emission reductions from existing federal and state measures,
plus any additional RACM/RACT that are adopted by the state to attain
``as expeditiously as practicable.'' Air quality modeling of these
projected emissions reductions in future years is an important element
of the attainment demonstration.
    Each nonattainment SIP must include RACM/RACT as necessary for the
area to attain the 2008 Lead NAAQS. The CAA requires the state to
demonstrate that it has adopted all RACM, considering economic and
technical feasibility and other factors, that are needed to show that
the area will attain the lead standards as expeditiously as
practicable. The 2008 Lead NAAQS Rule sets forth more specific guidance
for making RACM and RACT determinations.
    Each plan must also ensure that the area is making RFP in terms of
emission reductions and air quality improvements toward attainment. The

2008 Lead NAAQS Rule provides that the RFP element of a SIP include a
detailed schedule for the implementation of RACM (including RACT) that
accurately indicates the corresponding annual emission reductions to be
achieved.
    SIPs must also include contingency measures, which are emission
reduction measures to be undertaken if the area fails to satisfy the
RFP requirement or fails to attain the 2008 Lead NAAQS by the
attainment date. These measures are to take effect without significant
further action by the state or the EPA. As discussed in the 2008 Lead
NAAQS Rule, the EPA generally expects that contingency measures will be
implemented as expeditiously as practicable, and will be fully
implemented within 60 days of the EPA notifying the state that
contingency measures are necessary.

B. The EPA's Clean Data Policy

    The Clean Data Policy represents the EPA's interpretation that
certain requirements of subpart 1 of part D of title I of the Act are
by their terms not applicable to areas that are attaining the NAAQS.\2\
The specific requirements that are inapplicable to an area attaining
the standard are the requirements to submit a SIP that provides for:
attainment of the NAAQS, implementation of all RACM, RFP and
implementation of contingency measures for failure to meet deadlines
for RFP and attainment. The EPA has previously applied the Clean Data
Policy to the 2008 Lead NAAQS. See e.g., 77 FR 35653 (June 14, 2012)
(proposed determination of attainment of the 2008 lead standards for
Bristol, TN); 77 FR 52232 (August 29, 2012) (final rule). For more
information about the history, rationale and application of the Clean
Data Policy, see 77 FR 35653-35654.
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    \2\ This discussion refers to subpart 1 because subparts 1 and 5
contain the requirements relating to attainment of the lead NAAQS.
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    We note that several lead nonattainment areas currently have air
quality that attains the 2008 Lead NAAQS, but have not yet completed
the process for redesignating the area to attainment. Where the EPA has
published in the Federal Register a clean data determination for an
area, a state's obligation to submit RACM/RACT, contingency measures,
RFP and attainment demonstrations for that area are suspended as of the
effective date of the clean air determination. This suspension will
remain in effect unless the EPA subsequently determines, after notice-
and-comment rulemaking, that the area has again violated the 2008 Lead
NAAQS, in which case the requirements are again due or the area is
redesignated to attainment, in which case the requirements are
permanently no longer applicable. Thus, states with areas that have
received final clean data determinations and have not submitted SIPs
for these areas are not subject to the final action in this rule.

III. Findings of Failure To Submit for Pennsylvania for Attainment SIPs
for the 2008 Lead NAAQS

    Section 179(a)(1) of the CAA establishes specific consequences if
the EPA finds that a state has failed to submit a SIP or, with regard
to a submitted SIP, if the EPA determines it is incomplete or if the
EPA disapproves it. Additionally, any of these findings also triggers
an obligation for the EPA to promulgate a FIP if the state has not
submitted, and the EPA has not approved, the required SIP within 2
years of the finding.
    The EPA is finding that Pennsylvania has failed to make the
required nonattainment SIP submissions for the Lyons and North Reading
nonattainment areas in Berks County and the Lower Beaver Valley
nonattainment area in Beaver County. If the EPA has not affirmatively
determined that Pennsylvania has made the required complete
nonattainment SIP submissions within 18 months of the effective date of
this action then, pursuant to CAA section 179(a) and (b) and 40 CFR
52.31, the offset sanction identified in CAA section 179(b)(2) will
apply in any area subject to the findings for which a complete
submission has not been made. If the EPA has not affirmatively
determined that Pennsylvania has made a complete submission for each
area subject to the findings within 6 months after the emission offset
sanction is imposed, then the highway funding sanction will also apply
in any area subject to the finding for which a complete submission has
not been made, in accordance with CAA section 179(b)(1) and 40 CFR
52.31. The 18-month clock will stop and the sanctions will not take
effect, within 18 months after the date of this finding, if the EPA
finds that Pennsylvania has made a complete nonattainment SIP
submission for each area for which the finding is being made or if the
EPA makes a determination the area is attaining the standard consistent
with the EPA's Clean Data Policy. In addition, the EPA is not required
to promulgate a FIP if Pennsylvania makes the required SIP submittal,
and the EPA takes final action to approve the submittal, or if EPA
makes a final determination the area is attaining the standard
consistent with the Clean Data Policy, within 2 years of the EPA's
finding. Contemporaneous with the signing of this rule, the EPA Region
3 Regional Administrator is sending a letter to the governor of
Pennsylvania informing the governor that the EPA is determining that
Pennsylvania has failed to make the required SIP submissions for the
specified areas. This letter and any accompanying enclosures have been
included in the docket for this action.

IV. This Action

    In this action, the EPA is making a finding of failure to submit
for Pennsylvania with regard to areas designated nonattainment for lead
in 2010. Pennsylvania has not yet submitted attainment SIPs for three
nonattainment areas--the Lyons and North Reading nonattainment areas in
Berks County and the Lower Beaver Valley nonattainment area in Beaver
County.
    In accordance with CAA section 179, this finding starts the 18-
month emission offset sanctions clock, the 24-month highway funding
sanctions clock and a 24-month clock for the promulgation by the EPA of
a FIP. This action will be effective on February 25, 2014.

V. Statutory and Executive Order (EO) Reviews

A. Executive Order 12866: Regulatory Planning and Executive Order
13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review under EO 12866 and 13563 (76 FR
3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
This final action does not establish any new information collection
requirement apart from that already required by law. This action makes
a finding that Pennsylvania failed to submit attainment SIPs for the
2008 Lead NAAQS as required by the CAA. Burden means the total time,
effort or financial resources expended by persons to generate,
maintain, retain, disclose or provide information to or for a federal
agency. This includes the time needed to review instructions; develop,
acquire,

install and utilize technology and systems for the purposes of
collecting, validating and verifying information, processing and
maintaining information and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information. An agency may not conduct or sponsor and a person is not
required to respond to a collection of information unless it displays a
currently valid Office of Management and Budget (OMB) control number.
The OMB control numbers for the EPA's regulations in the CFR are listed
in 40 CFR Part 9.

C. Regulatory Flexibility Act (RFA)

    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 APA 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 the purpose of assessing the impacts of
this final action on small entities, small entity is defined as: (1) A
small business that is a small industry entity as defined in the U.S.
Small Business Administration (SBA) size standards (See 13 CFR 121);
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of this final action on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
action will not impose any requirements on small entities. This action
makes a finding that Pennsylvania failed to submit attainment SIPs for
the 2008 Lead NAAQS as required by the CAA.

D. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action contains no federal mandate under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-
1538 for state, local and tribal governments and the private sector.
The action imposes no enforceable duty on any state, local or tribal
governments or the private sector, because the requirement to submit an
attainment SIP is established in the Clean Air Act. Therefore, this
action is not subject to the requirements of section 202 and 205 of the
UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This action makes a
finding that Pennsylvania failed to submit attainment SIPs for the 2008
Lead NAAQS as required by the CAA.

E. Executive Order 13132: Federalism

    EO 13132, titled ``Federalism'' (64 FR 43255, August 10, 1999),
requires the EPA to develop an accountable process to ensure
``meaningful and timely input by state and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the EO to
include regulations that have ``substantial direct effects on the
states or the relationship between the national government and the
states, or on the distribution of power and responsibilities among the
various levels of government.'' This final action does not have
federalism implications. It will not have substantial direct effects on
the states, on the relationship between the national government and the
states, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132.
The CAA establishes the scheme whereby states take the lead in
developing plans to meet the NAAQS. This action will not modify the
relationship of the states and the EPA for purposes of developing
programs to implement the NAAQS. Thus, Executive Order 13132 does not
apply to this action.

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

    EO 13175, titled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), requires the EPA to
develop an accountable process to ensure ``meaningful and timely input
by Tribal officials in the development of regulatory policies that have
Tribal implications.'' This final action does not have tribal
implications, as specified in EO 13175. This action responds to the
requirement in the CAA for states to submit nonattainment SIPs for the
2008 Lead NAAQS.

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

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying only to those regulatory actions that concern health
or safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is subject to Executive Order 13045 because it is making
findings that Pennsylvania failed to submit nonattainment SIPs for the
2008 Lead NAAQS as required by the CAA. The enforceable measures in the
attainment SIPs will ensure that the areas will attain the NAAQS for
lead, which was established to protect public health, including the
health of children, with an adequate margin of safety.

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

    This action is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) because it is not likely to have a significant
adverse effect on the supply, distribution or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA of 1995 Public Law 104-113, section
12(d) (15 U.S.C. 272 note) directs the EPA to use voluntary consensus
standards (VCS) in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impracticable. VCS are
technical standards (e.g., materials specifications, test methods,
sampling procedures and business practices) that are developed or
adopted by VCS bodies. The NTTAA directs the EPA to provide Congress,
through OMB, explanations when the agency decides not to use available
and applicable VCS. This action does not involve technical standards.
Therefore, the EPA did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high

and adverse human health or environmental effects of their programs,
policies and activities on minority populations and low-income
populations in the United States. The EPA has determined that this
final action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
because it does not directly affect the level of protection provided to
human health or the environment. This rule is making a finding that
Pennsylvania failed to submit nonattainment SIPs for the 2008 Lead
NAAQS as required by the CAA. The enforceable measures in the
attainment SIPs will ensure that the areas will attain the NAAQS for
lead, which was established to protect public health, including the
health of minority and low income populations, with an adequate margin
of safety.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the action in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This action will be effective February 25, 2014.

L. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the Third Circuit within 60 days from the date this action is published
in the Federal Register. Filing a petition for reconsideration by the
Administrator of this final action does not affect the finality of this
action for the purposes of judicial review nor does it extend the time
within which a petition for judicial review must be filed, and shall
not postpone the effectiveness of this action.

List of Subjects in 40 CFR Part 52

    Environmental protection, Approval and promulgation of
implementation plans, Administrative practice and procedures, Air
pollution control, Incorporation by reference, Intergovernmental
relations, and Reporting and recordkeeping requirements.

    Dated: February 7, 2014.
Janet G. McCabe,
Acting Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2014-03329 Filed 2-24-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25811-25812]
[FR Doc No: 2019-11519]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1707]

Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of
Five Abbreviated New Drug Applications for Pemoline Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the
approval of five abbreviated new drug applications (ANDAs) for products
containing pemoline. The holders of the applications requested
withdrawal of the applications and have waived their opportunity for a
hearing.

DATES: Approval is withdrawn as of June 4, 2019.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: FDA approved the following ANDAs for
pemoline tablets for the conditions of use in the labeling of new drug
application (NDA) 016832, the reference listed drug on which these
ANDAs relied:

 ANDA 075030 approved on January 29, 1999
 ANDA 075287 approved on September 18, 2000
 ANDA 075595 approved on February 28, 2000

    FDA approved the following ANDAs for pemoline chewable tablets for
the conditions of use in the labeling of NDA 017703, the reference
listed drug on which these ANDAs relied:

 ANDA 075555 approved on February 18, 2000
 ANDA 075678 approved on July 26, 2000

    On October 24, 2005, FDA issued a Postmarket Drug Safety
Information for Healthcare Professionals communication stating its
conclusion that the overall liver toxicity risk of CYLERT (NDAs 016832
and 017703) and generic pemoline products outweighed the benefits of
these products (https://wayback.archive-it.org/7993/20171114124349/
https://www.fda.gov/DrugsDrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/

ucm126461.htm). The applicants and other holders of approved
applications for pemoline products ceased marketing the products at
that time.
    On August 10, 2018, the applicants listed in the table below
requested that FDA withdraw approval of the pemoline ANDAs listed in
the table under Sec.  314.150(d) (21 CFR 314.150(d)), and, in doing so,
waived their opportunity for a hearing. For the reasons discussed
above, which the applicants do not dispute in their withdrawal request
letters, and pursuant to the applicants' requests, FDA is withdrawing
approval of the ANDAs listed in the table, and all amendments and
supplements thereto, under Sec.  314.150(d). Tablet strengths listed in
the table below include all strengths FDA has identified as being
previously approved under these ANDAs. In each case, approval of the
entire application is withdrawn, including any strengths inadvertently
missing from the table. Distribution of these products in interstate
commerce without an approved application is illegal and subject to
regulatory action (see sections 505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d), respectively).

------------------------------------------------------------------------
        Application No.                 Drug              Applicant
------------------------------------------------------------------------
ANDA 075030...................  Pemoline Tablets,    Teva
                                 18.75 mg, 37.5 mg,   Pharmaceuticals
                                 and 75 mg.           USA, Inc., 425
                                                      Privet Rd.,
                                                      Horsham, PA 19044.
ANDA 075287...................  Pemoline Tablets,    Watson
                                 18.75 mg, 37.5 mg,   Laboratories,
                                 and 75 mg.           Inc., 425 Privet
                                                      Rd., Horsham, PA
                                                      19044.
ANDA 075555...................  Pemoline Chewable    Teva
                                 Tablets, 37.5 mg.    Pharmaceuticals
                                                      USA, Inc.
ANDA 075595...................  Pemoline Tablets,    Actavis Elizabeth
                                 18.75 mg, 37.5 mg,   LLC, 425 Privet
                                 and 75 mg.           Rd., Horsham, PA
                                                      19044.
ANDA 075678...................  Pemoline Chewable    Do.
                                 Tablets, 37.5 mg.
------------------------------------------------------------------------

    Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11519 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P


The Agricultural Sector and Air Quality Sally Shaver Associate Counselor for Agricultural Policy Office of Air and Radiation September 9, 2005 2 Urban sprawl has raised public awareness of agriculturally generated pollution, leading EPA to develop a strategy which may require air emissions reductions. 3 While a number of environmental statutes and programs potentially apply to agricultural operations, traditionally, the CAA and CERCLA have not been applied to these sources. 4 EPA's goal would be:

To develop and implement a mix of voluntary and regulatory policies that will adequately address environmental pollution while supporting a healthy agricultural sector. 5 Environmental Statutes Potentially Impacting Animal Production ° Clean Water Act ( CWA)

  sources must get a National Pollutant Discharge Elimination System ( NPDES) permit prior to discharge of pollutants   authorizes EPA to develop guidelines ( i. e., Feedlot Effluent Limitation Guidelines)

° Comprehensive Environmental Response Compensation Liability Act ( CERCLA):

  requires reporting of releases to the National Response Center if equal to or greater than the " reportable quantities"

° ammonia   100 lbs/ day ° hydrogen sulfide   100 lbs/ day 6 Environmental Statutes Potentially Impacting Animal Production   cont.

° Clean Air Act ( CAA)

  establishes limits for criteria pollutants ( e. g., PM and ozone) and hazardous air pollutants and requires State plans on how to meet the limits   requires " major sources" to obtain title V permits   requires new source review permits prior to new construction or modification of a site   requires States to address their contributions to visibility impairment in Class I areas 7 Impacts of CAA Statutes and Programs on Animal Production ° PM and ozone State implementation plans   If area is nonattainment, State has to designate area   3 years after designation, SIPs are due which:

° demonstrate attainment ° provide enforceable requirements for reductions sufficient to reach attainment ° provide for attainment in X ( 5 10 ) years ° Title V permits   Many States are evaluating applicability of title V to the various operations at farms   In California, the permit program approval was withdrawn for the agricultural exemption, resulting in:

° litigation against EPA for approval of a deficient program ° EPA settled the suit and agreed to administer the title V program for agricultural sources in California   permit applications due for diesel engines in May 2003   permit applications due for nondiesel engine agricultural sources ( e. g., CAFOs) by August 2003 8 Impacts of CAA Statutes and Programs on Animal Production   cont.

° New source review   If a major source alters its operation such that emissions are increased, then a permit is required   The amount of increase in emissions varies with an area's nonattainment status   For attainment areas, PSD permits are required for increases >

250 tpy PM10, NOx or VOC ° Office of Enforcement and Compliance Assurance   A number of enforcement actions have been initiated since 1996   Recent enforcement actions were initially driven by violations of the Clean Water Act 9 Air Quality Issues ° Emissions of:

  volatile organic compounds ( VOC)

  hydrogen sulfide   ammonia ° PM2.5 from emissions of:

  particles ( ammonia as precursor)

  direct emissions ( dust)

° Nutrient over enrichment of aquatic systems from emissions of:

  ammonia ° Acidification of the environment from emissions of:

  ammonia ° Global climate change from greenhouse emissions of:

  methane   nitrous oxide 10 Scientific studies related to health and environmental effects EPA Criteria Document:

integrative assessment of scientific studies EPA Staff Paper:

policyrelevant assessments leading to staff recommendations on standards Scientific peer review of published studies Reviews by CASAC and the public Reviews by CASAC and the public Public hearings and comments on proposal EPA proposed decision on standards EPA final decision on standards Interagency review We are here PM NAAQS Review: Process 11 ° Final PM Air Quality Criteria Document  October 2004 ° Completion of PM Staff Paper:

  Second draft released for CASAC review and public comment January 31, 2005   CASAC review meeting April 6 7 and May 18, 2005   CASAC recommendations submitted to EPA June 6,

2005   Final PM Staff Paper by June 30, 2005 ° Rulemaking on PM NAAQS:

  Federal Register proposal to be signed by December 20,

2005   Public comment period: 90 days   Final Federal Register notice to be signed by September 27, 2006 PM NAAQS Review: Schedule 12 PM2.5 Implementation Guidance ° Final PM2.5 implementation rule  Sep 2004 ° Final PM2.5 designations  Dec 15, 2004 ° Proposed guidance developed   Apr 2004 ° Submitted for Office of Management and Budget review   Oct 2004 ° SIP are due for PM2.5 nonattainment areas ( 3 years after designation date)  Dec 2007 13 Counties Designated Nonattainment for PM10 Contigusa. shp Serious Moderate States. shp 01/ 2002 Classif ication For convenience the entire county is shown as nonattainment;

however, only a portion of many counties are designated nonattainment. 14 County Classification Rural Urban 1 Urban 2 15 Tons/ yr/ sq mi 0.0000512  0.00230 0.00231  0.00515 0.00516  0.0120 0.0121  0.0191 0.0192  0.0289 0.0290  0.0432 0.0433  0.0582 0.0583  0.103 0.104  0.273 0.274  1.80 2001 PM2.5 from Wildfires ( Tons/ Yr/ Sq Mi) 16 Ozone Implementation Schedule RACT SIPs due June 15 06* Final Phase 2 Implementation Rule ( in OMB review > 90 days)

Summer 05 Ozone attainment demonstration SIPs due June 15 07* EPA issued final designations & Final Phase I Implementation rule April 04 Range of attainment dates 2007 2024 Effective Date of Designations June 15 04 Action Date * proposed 17 Ozone NAAQS Review ° 1st draft ozone criteria document Jan 2005   CASAC/ public review May 2005 ° 2nd draft ozone criteria document Aug/ Sep 2005 ° 1st draft ozone staff paper Sep 2005   CASAC/ public review Dec 2005 ° Final ozone criteria document Feb 28, 2006 ° 2nd draft ozone staff paper Apr 2006   CASAC/ public review Jul 2006 18 8 hour Ozone and PM2.5 Nonattainment Counties Final April 5, 2005 PM2.5 Only Both 8 hour Ozone* and PM2.5 8 hour Ozone* only * Note: Ozone counties are shown as whole counties; however, in some cases,

only part of the county was designated as nonattainment PM2.5 Unclassifiable Areas Greenville Spartanburg, SC 19 The Path Forward ° To improve our understanding of environmental issues related to the agricultural sector, EPA has developed a threepronged strategy and is working closely with USDA and others to reduce emissions and improve air quality while supporting a sustainable agricultural sector. 20 Air Quality Strategy for Agriculture ° Basic elements of strategy will include:

  Scientific assessment   Outreach and education   Implementation/

compliance 21 Scientific Assessment ° Currently, we do not have adequate emissions estimates for this sector ° Develop understanding of emissions profiles ° Establish monitoring and measurement protocols ° Technology transfer ° Research agenda Ensure that we are all driven by a fundamental shift in thinking and practices based on sound science. 22 Outreach and Education ° Encourage partnerships between EPA, USDA and their established partners ° Utilize existing USDA infrastructure ( e. g., Extension Service, NRCS, land grant colleges and universities,

and Farm Bill programs)

° Offer annual workshops ° Active dialogue with Ag community Instill a long term commitment to working with the agricultural community; build respect and trust; and identify, promote and quantify new/ existing control technologies 23 Implementation ° Appropriate mix of voluntary & regulatory programs ° Utilize USDA infrastructure to implement air quality programs and compliance assistance ° Strategy where EPA sets air quality targets and USDA provides technical assistance Fully institute policies and practices to ensure that farming and land management communities continue to consider air quality as an integral part of resource management.


[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Proposed Rules]
[Pages 66767-66768]
[FR Doc No: 2012-27169]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0942; Directorate Identifier 2012-NE-24-AD]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Canada Corp. Turboshaft
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain serial number Pratt & Whitney Canada Corp. (P&WC) PW206B,
PW206B2, PW206C, PW207C, PW207D, PW207D1, PW207D2, and PW207E
turboshaft engines. This proposed AD was prompted by the discovery that
certain power turbine (PT) disks were made to specific heat codes that
may not achieve the maximum in-service life. This proposed AD would
require re-identification of the PT disk to a part number (P/N) with a
lower life limit. We are proposing this AD to prevent possible
uncontained PT disk failure and loss of helicopter control.

DATES: We must receive comments on this proposed AD by January 7, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this AD, contact Pratt &
Whitney Canada Corp., 1000 Marie-Victorin, Longueuil, Quebec, Canada,
J4G 1A1; phone<PHONE_NUMBER>; fax<PHONE_NUMBER>; Web site: www.pwc.ca.
You may view the referenced service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA.
For information on the availability of this material at the FAA, call
781-238-7125.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0942;
Directorate Identifier 2012-NE-24-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on 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
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    Transport Canada, which is the aviation authority for Canada, has
issued Canada AD CF-2012-23, dated July 26, 2012 (referred to
hereinafter as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Certain power turbine (PT) disks, part number (P/N) 3044188-01,
made to specific heat codes may not achieve the established maximum
in-service life when installed in Turbomachinery Assembly P/N
3058588. The PT disk in-service life for engines using this specific
PT disk and compressor turbine (CT) vane combination is reduced when
operated in a particular temperature and speed environment.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    P&WC has issued Alert Service Bulletin No. PW200-72-A28311,
Revision 2, dated July 24, 2012. P&WC has also issued Engine
Maintenance Manual (EMM) Temporary Revisions AL-3, AL-4, AL -12, AL-13,
AL-16, AL-18, AL-19, and AL-20, all dated June 5, 2012. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of Canada,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with Canada, they have notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are issuing this proposed AD because we evaluated all
information provided by Canada and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This proposed AD would require re-identification of the PT disk to
a P/N with a lower life limit.

Differences Between This Proposed AD and the MCAI

    The MCAI requires the re-identification or replacement of affected
PT disks for engines with other than Turbomachinery Assembly P/N
3058588 installations. This proposed AD would not.

Costs of Compliance

    We estimate that this proposed AD would affect about 83 engines
installed on helicopters of U.S. registry. We also estimate that it
would take about 4 hours per engine to comply with this proposed AD.
The average labor rate is $85 per hour. Prorated parts life will cost
about $8,900. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $766,920.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    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); and
    3. 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.
    4. We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

Pratt & Whitney Canada Corp. (Formerly Pratt & Whitney Canada Inc.):
Docket No. FAA-2012-0942; Directorate Identifier 2012-NE-24-AD.

(a) Comments Due Date

    We must receive comments by January 7, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pratt & Whitney Canada Corp. (P&WC) model
PW206B, PW206B2, PW206C, PW207C, PW207D, PW207D1, PW207D2, and
PW207E turboshaft engines.

(d) Reason

    This AD was prompted by certain power turbine (PT) disks, part
number (P/N) 3044188-01, made to specific heat codes that may not
achieve the established maximum in-service life when installed in
Turbomachinery Assembly P/N 3058588. The PT disk in-service life for
engines using this specific PT disk and compressor turbine vane
combination is reduced when operated in a particular temperature and
speed environment. We are issuing this AD to prevent possible
uncontained PT disk failure and loss of helicopter control.

(e) Actions and Compliance

    Unless already done, do the following actions.

(f) Affected PT Disks Installed With Turbomachinery Assembly P/N
3058588 Installation

    (1) For any PT disk P/N 3044188-01 that is listed by serial
number (S/N) in Table 1 of P&WC Alert Service Bulletin (ASB) No.
PW200-72-A28311, Revision 2, dated July 24, 2012, and, that is
installed or that had previously been installed with Turbomachinery
Assembly P/N 3058588 installation, do the following:
    (i) Remove the PT disk P/N 3044188-01 from service before it
reaches 10,000 cycles-since-new (CSN).
    (ii) Re-identify the PT disk to P/N 3072542-01, at the next
engine shop visit, not to exceed 10,000 CSN on the PT disk, before
reinstalling it in any engine. Use paragraphs 3.B.(1) through
3.B.(1)(b)4 of the Accomplishment Instructions of P&WC ASB No.
PW200-72-A28311, Revision 2, dated July 24, 2012, to do the re-
identification.
    (iii) After re-identification of the PT disk to P/N 3072542-01,
retain the total cycles accumulated as P/N 3044188-01. The cycles
remaining on the re-identified P/N 3072542-01 PT disk must be
calculated using the difference between the published life limit of
P/N 3072542-01 and the total number of cycles accumulated as P/N
3044188-01. The maximum in-service life of PT disk P/N 3072542-01 is
10,000 CSN.
    (2) After the effective date of this AD, do not install any PT
disk P/N 3044188-01 that is listed in Table 1 of P&WC ASB No. PW200-
72-A28311, Revision 2, dated July 24, 2012, in any engine with
Turbomachinery Assembly P/N 3058588 installation, unless the PT disk
has been re-identified to P/N 3072542-01. Use paragraphs 3.B.(1)
through 3.B.(1)(b)4 of the Accomplishment Instructions of P&WC ASB
No. PW200-72-A28311, Revision 2, dated July 24, 2012, to do the PT
disk re-identification.

(g) Credit for Actions Accomplished in Accordance With Previous Service
Information

    You may take credit for the re-identification of the PT disk
that is required by this AD if you performed the re-identification
before the effective date of this AD using P&WC ASB No. PW200-72-
A28311, dated March 1, 2012, or P&WC ASB No. PW200-72-A28311,
Revision 1, dated March 22, 2012.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(i) Related Information

    (1) For more information about this AD, contact James Lawrence,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to Transport Canada AD CF-2012-23, dated July 26,
2012, and P&WC Alert Service Bulletin No. PW200-72-A28311, Revision
2, dated July 24, 2012, for related information.
    (3) The Engine Maintenance Manual (EMM) Temporary Revisions
(TRs) listed in Table 1 to paragraph (i)(3) pertain to the subject
of this AD.

                  Table 1 to Paragraph (i)(3)--EMM TRs
------------------------------------------------------------------------
                EMM P/Ns:                             TR Nos.:
------------------------------------------------------------------------
3071602..................................  AL-3, AL-4.
3043612..................................  AL-12, AL-13.
3043322..................................  AL-16.
3039732..................................  AL-18, AL-19.
3038324..................................  AL-20.
------------------------------------------------------------------------

     (4) For service information identified in this AD, contact
Pratt & Whitney Canada Corp., 1000 Marie-Victorin, Longueuil,
Quebec, Canada, J4G 1A1; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Web
site: www.pwc.ca. You may view the referenced service information at
the FAA, Engine & Propeller Directorate, 12 New England Executive
Park, Burlington, MA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on October 29, 2012.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2012-27169 Filed 11-6-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 28 (Thursday, February 10, 2011)]
[Proposed Rules]
[Page 7515]
[FR Doc No: 2011-2986]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0582; Airspace Docket No. 10-AEA-15]

Proposed Establishment of Class E Airspace; Kenbridge, VA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM); withdrawal.

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

SUMMARY: This action withdraws the NPRM published in the Federal
Register on November 29, 2010, which proposed to establish Class E
airspace at Lunenburg County Airport, Kenbridge, VA. The NPRM is being
withdrawn as a portion of the proposed airspace was not included. A new
rulemaking will be forthcoming to correctly establish the new airspace.

DATES: Effective 0901 UTC, February 10, 2011, the proposed rule
published November 29, 2010, at 75 FR 73016, is withdrawn.

FOR FURTHER INFORMATION CONTACT: Richard Horrocks, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On November 29, 2010, a NPRM was published in the Federal Register
to establish Class E airspace at Kenbridge, VA to accommodate special
standard instrument approach procedure for Lunenburg County Airport (75
FR 73016) Docket No. FAA-2010-0582. After publication the FAA found
that the airspace description in the proposed rule inadvertently
excluded extensions necessary for the airport legal description. To
avoid confusion this proposed rule is being withdrawn and will be
established under another rulemaking.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Withdrawal

    Accordingly, pursuant to the authority delegated to me, the Notice
of Proposed Rulemaking, Airspace Docket No. 10-AEA-15, as published in
the Federal Register on November 29, 2010 (75 FR 73016) (FR Doc. 2010-
0582), is hereby withdrawn.

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    Issued in College Park, Georgia, on January 25, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-2986 Filed 2-9-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46690-46691]
[FR Doc No: 2020-16740]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4552-DR; Docket ID FEMA-2020-0001]

Missouri; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Missouri (FEMA-4552-DR), dated July 9, 2020,
and related determinations.

DATES: The declaration was issued July 9, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 9, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Missouri resulting from severe storms, tornadoes, straight-line
winds, and flooding during the period of May 3 to May 4, 2020, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Missouri.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, John Brogan, of FEMA is appointed to
act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Missouri have been designated
as adversely affected by this major disaster:

    Bates, Butler, Carter, Dallas, Douglas, Dunklin, Henry, Hickory,
Howell, Laclede, New Madrid, Oregon, Pemiscot, Polk, Ripley,
Shannon, Stoddard, Wayne, and Wright Counties for Public Assistance.
    All areas within the State of Missouri are eligible for
assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-16740 Filed 7-31-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 28 (Thursday, February 10, 2011)]
[Proposed Rules]
[Pages 7513-7515]
[FR Doc No: 2011-2952]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0041; Directorate Identifier 2010-NM-227-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 747-400 and -
400F Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD would require a general visual
inspection for cracks and holes of the main equipment center (MEC) drip
shields, and repairs if necessary; installation of a fiberglass
reinforcing overcoat; and, for certain airplanes, installation of
stiffening panels to the MEC drip shields. This proposed AD was
prompted by a report of a loss of bus control unit number 1 and
generator control units numbers 1 and 2 while the airplane was on the
ground, and multiple operator reports of cracked MEC drip shields. We
are proposing this AD to prevent water penetration into the MEC, which
could result in the loss of flight critical systems.

DATES: We must receive comments on this proposed AD by March 28, 2011.

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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

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 proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Marcia Smith, Aerospace Engineer,
Cabin Safety & Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office (ACO), 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2011-0041;
Directorate Identifier 2010-NM-227-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed 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 proposed AD.

Discussion

    We have received a report of a loss of bus control unit number 1
and generator control units numbers 1 and 2 while the airplane was on
the ground, and multiple operators have reported cracked main equipment
center (MEC) drip shields. Cracking in the MEC drip shield and exhaust
plenum has been identified as part of the water leak path into the MEC.
This condition, if not corrected, could result in water penetration
into the MEC, which could result in the loss of flight critical
systems.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 747-25A3588, dated July
19, 2010. The service information describes procedures for performing a
general visual inspection of the MEC drip shield for cracks and holes,
performing repairs if necessary, and installing a fiberglass
reinforcing overcoat to the MEC drip shield. Additionally, for
airplanes identified as Groups 1 and 3, the service information
describes procedures for installing MEC drip shield panel stiffeners.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or

develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Costs of Compliance

    We estimate that this proposed AD affects 41 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost              Parts cost          product        operators
----------------------------------------------------------------------------------------------------------------
Inspection and installation:       20 work-hours x $85 per   $1,109.............          $2,809         $67,416
 Groups 1, 3 (24 airplanes).        hour = $1,700.
Inspection and installation:       17 work-hours x $85 per   Negligible.........           1,445          24,565
 Group 2 (17 airplanes).            hour = $1,445.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs that
would be required based on the results of the proposed inspection. We
have no way of determining the number of aircraft that might need these
repairs.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
             Action                      Labor cost              Parts cost             Cost per airplane
----------------------------------------------------------------------------------------------------------------
Hole repair.....................  1 work-hour x $85 per     Negligible.........  $85 per hole.
                                   hour = $85 per hole.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

The Boeing Company: Docket No. FAA-2011-0041; Directorate Identifier
2010-NM-227-AD.

Comments Due Date

    (a) We must receive comments by March 28, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to The Boeing Company Model 747-400 and -
400F series airplanes, certificated in any category, as identified
in Boeing Alert Service Bulletin 747-25A3588, dated July 19, 2010.

Subject

    (d) Joint Aircraft System Component (JASC)/Air Transport
Association (ATA) of America Code 25, Equipment/Furnishings.

Unsafe Condition

    (e) This AD was prompted by a report of a loss of bus control
unit number 1 and generator control units numbers 1 and 2 while the
airplane was on the ground, and multiple operator reports of cracked
main equipment center (MEC) drip shields. We are issuing this AD to
prevent water penetration into the MEC, which could result in the
loss of flight critical systems.

Compliance

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

Inspection

    (g) Within 24 months after the effective date of this AD, do the
actions specified in paragraph (g)(1) or (g)(2) of this AD, as
applicable, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 747-25A3588, dated July 19, 2010.
    (1) For Group 1 and Group 3 airplanes, as identified in Boeing
Alert Service Bulletin 747-25A3588, dated July 19, 2010: Do a
general visual inspection of the MEC drip

shield to detect cracking and holes; do all applicable repairs; and
install the MEC drip shield panel stiffeners and the fiberglass
reinforcing overcoat to the MEC drip shield; in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
25A3588, dated July 19, 2010. Do all applicable repairs before
further flight.
    (2) For Group 2 airplanes, as identified in Boeing Alert Service
Bulletin 747-25A3588, dated July 19, 2010: Do a general visual
inspection of the MEC drip shield to detect cracking and holes; do
all applicable repairs; and install the fiberglass reinforcing
overcoat to the MEC drip shield; in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
25A3588, dated July 19, 2010. Do all applicable repairs before
further flight.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be e-mailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

Related Information

    (i) For more information about this AD, contact Marcia Smith,
Aerospace Engineer, Cabin Safety & Environmental Systems Branch,
ANM-150S FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    (j) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 3, 2011.
Ali Bahrami,
Manager,Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2011-2952 Filed 2-9-11; 8:45 am]
BILLING CODE 4910-13-P