NOMINATION OF THE AEROSOL METERED-DOSE INHALER (MDI)

AS AN ESSENTIAL USE FOR 2008

Country:			United States

Contact Person:		John Thompson

Title:				Division Director

Address:  			U.S. Department of State

	Washington, DC 20520

Telephone:		 	202/647-9799

Fax:				202/647-5947

Email<EMAIL_ADDRESS>
Expert Contact Person*:	Hodayah Finman

Title:				Team Leader

Address:  			U.S. Environmental Protection Agency

				Office of Air and Radiation (6205J)

	1200 Pennsylvania Avenue, NW

	Washington, DC 20460

Telephone:			202/343-9246

Fax:				202/343-2338

Email<EMAIL_ADDRESS>
*	Expert(s) in the country who can be contacted for clarification.

I.	Summary of Nomination

Please identify and describe in detail the proposed uses.  Please
indicate for what disease or treatment the proposed use is intended.
(Decision IV/25, pars. 2 and 3)

The proposed use is Metered Dose Inhalers (MDI) where the active
ingredient is not solely salbutamol for the treatment of asthma and
chronic obstructive pulmonary disease (COPD).  MDIs are pocket-sized
aerosol devices used to deliver (orally) precisely measured doses of
medicine directly to the lungs.

CFCs are used as propellants and suspension agents in MDIs (CFC-11,12
and 114).  They are also used in the manufacture of MDI valves and in
cleaning MDI manufacturing equipment.

In this nomination, the U.S. is not requesting CFCs for 2008 for use in
metered-dose inhalers where the sole active ingredient is salbutamol.
The U.S. established a phaseout date of December 31, 2008 for these
products, after which time they will be illegal to sell.

It is the intention of the U.S. government not to file a 2008 essential
use exemption request for CFCs for use in metered-dose inhalers where
the sole active ingredient is salbutamol.  However, the 2005 and 2006
allocation rules that make CFCs available for essential uses were
significantly delayed and it is   uncertain at this time what impact
that may have on supplies of salbutamol products in the early part of
2008.  Therefore, the U.S. reserves the right to submit a 2008
nomination for use in products where the sole active ingredient is
salbutamol next year in January 2007 should there be an essential need
to do so.

Please specify the active ingredient(s) used.  (Decision IV/25, pars. 2
and 3)

	Flunisolide, Metaproterenol, Ipratropium and Salbutamol (in
combination), 	Pirbuterol, Epinephrine, Triamcinolone, Cromolyn and,
Nedocromil.

Please identify the intended market(s) for sale or distribution for each
active ingredient.  (Decision XV/5, par. 2)

	Information pursuant to Decision XV/5 will be submitted by the United
States 	under separate cover for confidentiality reasons.  Please note,
the U.S. is not 	nominating CFCs for MDIs to meet export demand.

Please indicate below the quantity of CFCs requested for the proposed
use in each year being nominated for each active ingredient and for each
intended market for sale or distribution; if necessary, the quantities
for intended markets may be best estimates from requesting companies.
If more specific data are not available, data aggregated by region and
product group may be submitted for Article 5(1) intended markets for
sale or distribution.  (Decision IV/25, pars. 2 and 3 and Decision XV/5,
par. 2)

Nominated quantities of CFCs (metric tonnes) for essential uses

Ozone Depleting Substance	2008 Quantity (metric tonnes)

CFC-11, CFC-12, and CFC-114	384.97  metric tones (see p.15 as well)

	As noted above, specific data on the amount of CFCs by active
ingredient 	requested in Decision XV/5 will be provided under separate
cover due to 	confidentiality concerns.

II.	Substantiation of Nomination

A.	Role in Society

1.	State whether the nomination is for the treatment of asthma and/or
chronic obstructive pulmonary disease.  If not, explain why this use is
necessary for health and/or safety or critical for the functioning of
society?  (Decision IV/25, p 2 and 3)

●	Describe the nature of the disease(s) that the proposed use is
intended to treat, e.g., the nature and prevalence of the disease and
the role of MDIs (versus other forms of therapy) in treating the
disease(s).

This nomination requests CFCs solely for use in MDIs for the treatment
of asthma and/or COPD.  Asthma and chronic obstructive pulmonary
diseases (COPD), such as emphysema and chronic bronchitis, reduce the
capacity for breathing.  In asthma and often in COPD, airways become
inflamed and hyper-reactive, causing coughing and wheezing that disrupts
breathing.  These diseases can also cause swelling of the bronchi and
produce mucus plugs that further impede airflow.  In addition, nervous
system stimulation can contribute to further airway narrowing and
worsening symptoms.  Finally, in the case of emphysema and chronic
bronchitis, this process gradually destroys the surface area of the
lung, reducing its capacity to exchange oxygen and carbon dioxide.
Asthma and COPD greatly diminish the quality of life for patients and
their families, and in severe cases may cause death.

Asthma is a chronic and debilitating respiratory disease with sudden,
unpredictable and potentially life-threatening effects.  The treatment
of asthma requires constant vigilance and the active involvement of
patients, families, physicians and other care-givers in a comprehensive
program to monitor, anticipate and promptly respond to the onset of
asthmatic attacks.

Patients with asthma may be restricted from normal physical activity,
may be limited in their choice of work, afflicted by the side effects of
some medications, and subject to unpredictable and sudden asthma attacks
which disrupt their daily activities and may even threaten their lives.

Chronic obstructive pulmonary disease produces inflammation, swelling,
and mucus in the human airway, and gradually destroys the surface area
of the lung.  COPD is progressive and generally irreversible, and
severely restricts the capacity for respiration.

In its April 1999 report, the Technology and Economic Assessment Panel
stated that: “there is international consensus that primary treatment
of [asthma and COPD] should be by the inhaled route.  This permits
treatment to be delivered quickly and efficiently to the airways, which
minimizes risk of adverse reactions.  Therapy necessitates regular
treatment, often with more than one drug.  MDIs remain the dominant
inhaled delivery system in most countries and for all categories of
drugs.”

The American Lung Association has issued a publication entitled “Lung
Disease Data 2000" which contains statistics concerning the prevalence,
mortality, and treatment of asthma and COPD in the United States.  The
report states that:

There are approximately 17 million asthma sufferers in the U.S.  Asthma
is now the sixth-ranking chronic condition and the leading serious
chronic illness in children.  (p. 5 ).

“Asthma is unquestionably, and unaccountably, on the rise”.  Between
1982 and 1995, the prevalence rate (the rate per thousand persons) of
asthma rose from 34.8 to 56.8, a 63% increase.  The prevalence of
pediatric asthma rose from 40.1 to 74.9, a 72.3% increase. (p. 5)

There were 5,434 deaths from asthma recorded in 1997.  This represents
more than a two-fold increase since 1979. (p. 7)

Asthma attacks bring an estimated 1.9 million Americans to emergency
rooms each year and account for one in six of all pediatric emergency
room visits in the U.S.  (p. 5)

Asthma cost the U.S. an estimated $11.3 billion in 1998.  This amount
includes direct health care expenses ($7.5 billion) and indirect costs
such as lost productivity ($3.8 billion). (p. 5)

In addition to those with asthma, more than 16 million Americans are
estimated to suffer from COPD, and it is the fourth-ranking cause of
death in the United States. (p. 22)

COPD was responsible for the death of over 103,000 Americans in 1997.
This is a new high in a steadily increasing toll (the 1980 figure was
just over 53,000). (p.22)

COPD costs the nation approximately $26.0 billion each year, which
includes both health care expenditures ($13.6 billion) and indirect
costs ($12.4 billion). (p. 22-23)

COPD is the third-ranking condition necessitating at-home care. ( p.23)

The problem is not limited to the Unites States.

The total incidence of asthma is estimated to be around 5-8% worldwide.

According to the World Health Organization (WHO), worldwide rates of
asthma are rising, on average, by 50% every decade. (WHO Fact Sheet No.
206)

COPD is estimated to affect up to 15% of the population and is the fifth
leading cause of death worldwide.

Asthma and COPD result in approximately 3 million deaths annually.
(World Health Report 1997, WHO)

There have been significant advancements in the development of
alternatives since the beginning of the essential use exemption program.
 As a result, the U.S. government, for the first time since the
inception of the exemption program, is not nominating CFC MDIs where the
sole active ingredient is salbutamol for an exemption.  The United
States has begun rulemaking processes this year to examine the
essentiality of MDIs where the sole active ingredient is not salbutamol
that use CFCs as well.

The need for an essential use exemption remains while we develop
suitable alternatives for certain uses or complete the transition to
CFC-free alternatives in other products.  Exempted CFC consumption for
products to treat asthma and COPD in the United States is necessary in
2008 for the health, safety and critical functioning of society due to
the prevalence and seriousness of these diseases.

2. Does this use include any MDI product approved after 31 December 2000
for

the treatment of asthma and/or chronic obstructive pulmonary disease?
(Decision

II/2, par. 2)

No.

B. 	Description of Transition Status

	The following elements should be addressed or updated in each year's
nomination:

1. 	Has a transition strategy applicable to the intended market(s) for
sale or 	distribution and a plan of action been submitted to the UNEP
Ozone 	Secretariat under Decision XII/2, or IX/19, and XV/5?  (Decisions
IX/19, 	par. 5, XII/2, par. 5(c)), and XV/5, par. 4.

	Consistent with the request of the Parties in Decision VIII/12, the
United States has submitted to the UNEP Ozone Secretariat its transition
strategy in the form of regulations developed by the U.S. Food and Drug
Administration (USFDA).  These regulations describe the criteria that
USFDA will use to determine when it is appropriate to remove the
essential use designation from products that use ozone-depleting
substances.  The final regulations were published in the Federal
Register on July 24, 2002.  The rule may be accessed on the USFDA
website at   HYPERLINK
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by searching
for rules published on July 24, 2002.  The USFDA issued a final rule on
April 4, 2005 (70 FR 17169) that sets the date to remove the essential
use designation for CFC MDIs whose active ingredient is salbutamol,
reflecting substantial progress towards phaseout of essential uses in
the U.S.  Please see Section 5 of this document for more information on
the USFDA rulemaking process.

2.	Explain, if known, how any such transition strategy applies to the
active ingredients(s) for each intended market for sale or distribution
as set forth above.  (Decision XV/5, par. 3)

	Decision XV/5 requests the TEAP to provide recommendations to the
Parties with reference to a national transition strategy covering the
intended market.  The United States is nominating CFCs solely for
domestic use and therefore our transition strategy as a whole applies to
the entire intended market.

3. 	Describe progress in the transition to alternatives pursuant to the
national or regional transition strategy submitted to the Secretariat in
the domestic market.  (Decision XII/2, par. 5(c))

Significant progress has been made in recent years to facilitate an
orderly transition to safe and effective CFC-free alternatives.
Following substantial investment in research and development by U.S.
firms, and completion of the required safety tests for new drug
products, USFDA has approved several new treatments for asthma and COPD
that do not rely on CFCs (see the table below).  Additional alternatives
are under review by USFDA.  Also, the U.S. Government has overseen the
consistent application of Decisions by the Parties regarding the
allocation of essential use allowances by ensuring that the amount
granted by the Parties is not allocated if it is not needed nationally.
In 2002 USFDA issued the final regulations that provide the framework
for the transition to CFC-free alternatives in the United States.  These
regulations describe the criteria for determining if a product using
ODSs is no longer medically essential.  The USFDA finalized their first
action to remove the essentiality of a medical device in 2004 with the
ban on the sale and distribution of CFC salbutamol MDIs effective
December 31, 2008.  The accelerating shift by U.S. firms to CFC-free
products, as well as the success of these products in the U.S. market,
is reflected in the more than 50% reduction in the 2008 U.S. nomination
as compared to the total approved by the Parties for the U.S. for
consumption in 2007 (the 2008 amount is approximately one third of the
U.S. 2007 nomination).

There are several factors that affect the timetable for the introduction
of alternatives and substitutes including:

The length of time necessary for research and development of alternate
products;

The time required to seek USFDA approval of new therapies;

The regulatory process to determine that a medical device is no longer
essential.

The process for determining the essentiality of a product is described
in a final rule developed by the USFDA.  The final rule was published in
the Federal Register of July 24, 2002 (67 FR 48370) (the 2002 final
rule) (corrected in 67 FR 49396, July 30, 2002, and 67 FR 58678,
September 17, 2002). The rule set standards that FDA would use for
determining whether the use of an ODS in a medical product is no longer
essential.

All CFC MDI’s where the sole active ingredient is not salbutamol
currently marketed in the United States do not have acceptable
alternatives with the same active moieties.  The standard to remove an
essential-use designation for products where there are not adequate
alternatives available with the same active moiety provide that FDA must
find that:

Substantial technical barriers do not exist to formulating the product
without ODS;

The product does not provide an unavailable important public health
benefits; and

Use of the product releases cumulatively significant amounts of ODS into
the atmosphere or the release is warranted in view of the unavailable
important public health benefits.

This is the standard that is being used in the current rulemakings
regarding the essential use status of MDIs where the sole active
ingredient is not salbutamol.

4.	Briefly describe the action plan adopted by the Party pursuant to
paragraphs 4 and 5 of decision XV/5 (providing for plans of action
including a specific phase-out date for salbutamol CFC MDIs sold or
distributed in non-Article 5 Parties, specific measures and actions
sufficient 	to deliver the phase-out; and actions and measures needed to
ensure 	continuing access to or supply of CFC-containing MDIs by Article
5 	Parties, where appropriate).  (Decision XV/5, pars. 4 and 5)

As indicated previously in this document, the United States has
established a

	phase-out date for the sale of CFC salbutomol products effective
December 31, 2008.  The U.S. has not traditionally exported CFC
salbutamol products to A5 countries but the EPA is currently evaluating
the amount of CFCs needed to meet demand for MDIs in Article 5 Parties
as part of the U.S. regulations on production for basic domestic needs.

5.	Describe progress made towards determining and submitting a specific
date by which time the Party will cease making nominations for essential
use exemptions for CFCs for metered-dose inhalers where the active
ingredient(s) is not solely salbutamol and the metered-dose inhalers are
expected to be sold or distributed on the market of any Party not
operating under paragraph 1 of Article 5.  (Decision XV/5, par. 6)

	The United States has begun rulemaking processes this year to examine
the potential phaseout of CFC MDIs where the active ingredient is not
solely salbutamol.  USFDA makes a determination on the essentiality of a
product through a public advisory process and accompanying notice and
comment rulemaking. This process may be a lengthy one taking years to
complete and is required by domestic law to ensure that an essentiality
determination is made with due consideration. The USFDA has already held
two advisory council meetings, which are a preliminary step for the
agency to begin consideration of this issue. As per Decision XVII/5, the
United States will inform the Ozone Secretariat as to the estimated
dates for publication of these proposed rules prior to the 18th MOP if
the proposed rules have not published by that time or an essential use
is not the subject of one of the current rulemakings.

6. 	Explain what substitutes and alternatives to the proposed use are
currently available in the domestic market and, to the extent known, in
each intended market for sale or distribution.  (Decision IV/25, pars.
1(a)(ii), 1(b)(i), 2 and 3(d))

Below is a list of CFC-free MDI and DPI products approved for the
treatment of asthma and COPD in the U.S. domestic market:

Product		Drug Delivery System		Active Moiety			Product Approval Date

Proventil HFA		HFA MDI		Salbutamol			15/08/96

Ventolin HFA                    HFA MDI	Salbutamol			19/04/01

Proais HFA                       HFA MDI	Salbutamol			29/10/04

Xepenex HFA                   HFA MDI
Levalbuterol                                     11/03/05

Q-Var 			HFA MDI		Beclomethasone			15/09/00

Advair Diskus		DPI			Fluticasone/salmeterol		24/08/01

Flovent Diskus		DPI			Fluticasone			29/09/00

Flovent HFA                     HFA MDI		Fluticasone			14/05/04

Pulmicort Turbuhaler        DPI
Budesonide	24/06/97

Serevent Diskus                DPI
Salmeterol	19/09/97

Asmanex Twisthaler         DPI
Mometasone                                     30/03/05

Atrovent HFA             HFA MDI
Ipratropium                                           27/11/05

In addition to the MDI and the DPI, three other forms of therapy exist
for the treatment of asthma and COPD:

orally administered drugs

injectable drugs

nebulizers

Orally administered and injectable drugs are prescribed for some
patients but rarely offer adequate relief by themselves.  As noted
elsewhere in the nomination, there is “international consensus that
primary treatment of these diseases should be by the inhaled route.”
Nebulizers are currently impractical replacements for MDIs due to issues
of portability and ease of use.  In its April 1999 report, the
Technology and Economic Assessment panel stated, “Novel oral compounds
(leukotriene modifiers) for the treatment of asthma have been introduced
in some countries.  These may be of value to a certain number of those
with asthma, but it is unlikely that these will be a full substitute for
current effective inhaled preventive therapy” (p. 191).

7. 	Explain steps being taken to implement these substitutes and
alternatives in the domestic market.  (Decision IV/25, pars. 1(a)(ii),
1(b)(i), 2 and 3(d))

List and describe in detail the education efforts being undertaken to
accomplish the transition.

Regulatory Actions to Facilitate Transition

Substantial progress has been made in recent years to facilitate an
orderly transition to safe and effective CFC-free alternatives.
Following substantial investment in research and development by U.S.
firms, and completion of the required safety tests for new drug
products, USFDA has approved several new treatments for asthma and COPD
that do not rely on CFCs (see the table under question 6). Additional
alternatives are under review by USFDA. In 2002 USFDA issued the final
regulations that provide the framework for the transition to CFC-free
alternatives in the United States. These regulations describe the
criteria for determining that a product using ODSs is no longer
medically essential.  Lastly, the U.S. Government has overseen the
consistent application of Decisions by the Parties regarding the
allocation of essential use allowances by ensuring that the amount
granted by the Parties is not allocated if it is not needed.  The
accelerating shift by U.S. firms to CFC-free products, as well as the
success of these products in the U.S. market, is reflected in the more
than 50% reduction in the 2008 U.S. nomination as compared to the total
approved by the Parties for consumption in the U.S. in 2007.  In fact,
depending on the outcome of the ongoing rulemaking process, the EPA
allocation of CFCs to manufacturers for 2008 may be substantially lower.

Removing Information Barriers: Government and Industry Activities

To encourage doctor and patient acceptance and use of CFC-free MDIs, MDI
companies in the U.S. will undertake national promotional campaigns that
include, among other things, meetings with and letters to health care
professionals, information booths at medical conferences,
advertisements, and distribution of educational materials introducing
these products into the market.  These steps will be taken in accordance
with relevant regulations of USFDA.

U.S. pharmaceutical companies have undertaken a number of education
efforts.  The International Pharmaceutical Aerosol Consortium (IPAC), to
which many U.S. MDI manufacturers belong, has undertaken the following
education efforts, some with the assistance of the U.S. Environmental
Protection Agency (U.S. EPA).  Some of these education efforts include:

World Wide Web Sites

USEPA and USFDA have websites with information on the transition to
CFC-free metered dose inhalers.  They are located at
www.fda.gov/cder/mdi/ and
http://www.epa.gov/ozone/title6/phaseout/mdi/index.html.

The International Pharmaceutical Aerosol Consortium (IPAC), to which
several companies operating in the U.S. belong, also has a World Wide
Web site (  HYPERLINK www.ipacmdi.com. www.ipacmdi.com).   The purpose
of the web site is to provide patients and physicians with information
on the transition to CFC-free MDIs.  The web site showcases IPAC
brochures, newsletters, fact sheets, and publications that IPAC
distributes at medical conferences and symposia.

Brochure on the Transition

A group of parties – USEPA, USFDA, the US National Institutes of
Health, IPAC, the National Asthma Education and Prevention Program of
the National Heart, Lung, and Blood Institute – collaborated in the
publication of a brochure entitled “Your Metered-Dose Inhaler Will Be
Changing. . . Here are the Facts.”  This brochure explains the reasons
why the CFC MDI is being replaced, the effort being made to develop and
introduce the CFC-free MDI, the ways in which the CFC-free MDI may
differ from the CFC MDI, and a list of organizations from which patients
and physicians may receive further information.

Outreach

The U.S. Government maintains an ongoing dialogue on the MDI transition
with a range of stakeholder organizations (pharmaceutical companies,
public health organizations, and patient and provider advocacy
organizations).  USEPA and USFDA participate in meetings of the US
Stakeholders Group on the MDI Transition, which meets under the auspices
of the American Lung Association.

In addition to the activities conducted by IPAC, individual companies in
the pharmaceutical industry promote respiratory education in many ways.
MDI companies often play a supporting role in the development of
respiratory symposia.  MDI pharmaceutical companies assist medical
professionals through in-service education programs, and by providing
reprints of articles and reports, as well as copies of educational aids
for distribution to patients.  Finally, MDI companies support
respiratory patient organizations through financial grants and the
distribution of educational aids.

Advertisements and other promotional materials are placed in medical
journals and circulated to prescribing physicians by pharmaceutical
companies to heighten medical professionals awareness of new respiratory
care products on the market, including MDIs and DPIs.

International professional associations such as the American Thoracic
Society (ATS), the American Academy of Allergy, Asthma, and Immunology
(AAAAI), and the European Respiratory Society (ERS) support medical
professionals active in the treatment of asthma and COPD.  These
associations publish medical journals, reports and newsletters and
organize medical congresses.  These activities are designed to inform
medical professionals about the management of asthma and COPD, and the
range of treatment options available for their patients.

Addressing Economic Barriers

To facilitate the transition away from CFC based salbutamol MDIs, a
number of U.S. pharmaceutical companies are creating programs to
distribute free or low cost HFA based alternatives to underserved
populations.  GSK has established a “Bridges to Access” program
which provides GSK drugs at very low cost to lower income individuals
and families.  In addition, GSK’s “Orange Card Program” and the
“Together Rx” program offer eligible Medicare patients the ability
to purchase drugs at significantly reduced prices.  Lastly, GSK intends
to annually distribute 2 million VENTOLIN HFA MDIs to physicians as
samples. A second major pharmaceutical company, Schering Plough,
established the “SP Cares” program, which is similar to GSK’s
Bridges to Access program to distribute free drugs, including PROVENTIL
HFA, to low-income uninsured patients.  These patient assistance
programs have the potential to alleviate difficulties that lower income
patients may have in obtaining the higher-priced salbutamol HFA MDIs.
These activities were factored into the USFDA determination that
salbutamol CFC MDIs will no loner be “essential” as of the end of
2008 and represent significant progress in the transition away from CFCs
for essential uses in the United States.

Explain why alternatives and substitutes are not sufficient or
appropriate to eliminate the proposed use.

MDIs possess numerous characteristics that, taken together, set them
apart from other inhalation delivery systems.  MDI propellants provide
the energy needed for drug delivery independent of any external power
source or extra inspiratory effort on the part of the patient.  In MDIs,
the delivered dose depends significantly on the metering valve and
formulation, not entirely on patient inspiration.  A patient who must
take multiple medications can operate a variety of MDIs using the same
technique.  MDIs provide very good protection from atmospheric humidity
and patient exhalation.  MDIs can be used for the inhalation of all of
the most commonly used respiratory medications and are widely available
for use with these medications.  They can be adapted to meet the needs
of special patient populations, including young children and infants.

Although seven MDIs with an alternative (non-CFC) propellant are
available in the U.S., these products represent only a fraction of the
many drugs currently available in an MDI format.  USFDA regulations
published in 2002 describe the criteria that the Agency uses to
determine when it is appropriate to remove the essential use designation
from products that use ozone-depleting substances.   One element of
these criteria is the availability of at least two alternatives for a
given use.  In some instances, such as the essential use designation for
salbutamol MDIs, there are at least two alternatives available to
patient and, therefore, the USFDA established a date for a ban on the
sale of CFC salbutamol MDIs.  While other CFC-free MDIs may be
introduced in the next few years, it is clear that CFC MDIs will still
be vital for the treatment of asthma and COPD in the U.S. for the near
future.

The 1993/94 UNEP Technical Options Report lists reasons why the MDI is a
vital therapy option.  These reasons remain pertinent today:

Nebulizers (1993/94 UNEP Technical Options Report, p. 49)

Most nebulizers "require a source of electricity or compressed gas, and
are very bulky and complicated to set up and use."

Currently available hand-held nebulizers are "inefficient."

Dose reproducibility in nebulizers "is not reliable."

Electric nebulizers require "10-20 minutes to deliver a dose."

	Oral Medication (1993/94 UNEP Technical Options Report, p. 50)

Oral medication usually produces "more side effects than inhaled
medication."

Some drugs which are effective by inhalation "are not absorbed as oral
therapy."

Treatment guidelines "have favoured a move from oral to inhaled route
for the treatment of respiratory diseases."

	Injectable Therapy (1993/94 Technical Options Report, p.50)

Injectable therapy “is not practical for general use in ambulatory
patients and is therefore reserved for the treatment of hospitalized
patients.”

Dry Powder Inhalers (1993/94 UNEP Technical Options Reports, pp. 48-49)

	DPIs are “difficult for patients with low inspiratory flow rates,
“e.g. small children, COPD patients, and asthmatics suffering 	from an
acute asthma attack.

DPIs require “special packaging for use in humid climates.”

Patient acceptance of DPIs “is not uniform.”

Describe how MDI manufacturers or distributors differentiate the
packaging of non-CFC MDIs from CFC-driven MDIs and describe what
marketing strategies are being taken to assure that their non-CFC MDIs
are used, and describe the steps that companies applying for essential
use exemptions have taken to obtain approval for CFC-free alternatives
in their domestic and export markets.

MDI companies have and will continue to differentiate the packaging for
CFC-free MDIs from the packaging of CFC MDIs through the use of shapes,
sizes, colors, trademarks, logos, and other design features.  In
addition, leaflets have been and will be included in the packages
containing CFC-free MDIs which inform patients of the differences
between the CFC-free MDI and the CFC MDI.  These steps have been and
will continue to be taken in accordance with relevant regulations of the
U.S. FDA (for example, 21 Code of Federal Regulations (CFR) Part 201
(dealing with labeling requirements for drugs) and Part 314 (dealing
with approval of new drugs).  Also, all CFC MDIs sold in the U.S. carry
a USEPA notification that the contents of the MDI includes CFCs.

To encourage doctor and patient acceptance and use of CFC-free MDIs, MDI
companies in the U.S. will undertake national promotional campaigns that
include, among other things, meetings with and letters to health care
professionals, information booths at medical conferences,
advertisements, and distribution of educational materials introducing
these products into the market.  These steps will be taken in accordance
with relevant regulations of USFDA.

Describe what steps have been taken to ensure that companies
manufacturing, distributing, or selling CFC MDIs and non- CFC
alternatives do not engage in false and misleading advertising targeted
at non-CFC alternatives or CFC MDIs.

The regulations of the USFDA prohibit advertisements which are false,
lacking in fair balance, or otherwise misleading (21 CFR 202(e)(5)).  An
advertisement shall be so deemed if, for example, it contains a
“representation or suggestion, not approved or permitted for use in
the labeling, that a drug is better, more effective, useful in a broader
range of conditions. . . than has been demonstrated by substantial
evidence or substantial clinical experience. . .” (21 CFR
202.1(e)(6)(i)).  The USFDA has a variety of means at its disposal to
enforce this requirement.  See generally sections 301, 502, and 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, and 355)
and 21 CFR Parts 202 and 314.U.S. Federal regulations may be accessed at
http://www.access.gpo.gov/su_docs/index.html.

Describe what steps have been taken to ensure that companies applying
for MDI essential use exemptions participate in regulatory proceedings
with a view toward legitimate environmental, health and safety concerns.

FDA regulations governing participation in regulatory proceedings
generally prohibit any company, including any MDI company, from
advancing environmental, health and safety concerns that are
illegitimate, or from otherwise engaging in conduct that misleads or
obfuscates.  These regulations require, among other things, that:

“All submissions to the Dockets Management Branch [of the USFDA] are
representations that, to the best of the knowledge, information, and
belief of the person making the submission, the statements made in the
submission are true and accurate.  All submissions are subject to the
False Reports to the Government Act (18 U.S.C. 1001) under which a
willfully false statement is a criminal offense” [21 CFR §10.20(i)];

Any company filing a “citizen petition” with the USFDA must certify
that the petition “includes representative data and information known
to the petitioner which are unfavorable to the petition” [21 CFR
§10.30(b)]; and

Knowingly and willingly making a materially false statement or
representation at a hearing that is part of a USFDA rulemaking process
is a felony under U.S. criminal law [18 U.S.C. 1001(a)].

8. 	Assure that each company requesting essential use allocations has
fully complied with Decision VIII/10.1 to demonstrate ongoing research
and development of alternatives to CFC MDIs with all due diligence
and/or collaborate with other companies in such efforts. (Decision
VIII/10,   par. 1)

All companies requesting essential use exemptions submitted information
to the U.S. government demonstrating their ongoing research and
development of alternatives to CFC MDIs.

9. 	Describe the steps to minimise emissions of CFCs during the
manufacture of the essential use products.  (Decision IV/25, pars.
1(b)(i), 2 and 3(b); Decision VI/9, par. 4; and Decision VIII/10, pars.
6 and 7)

The waste minimization strategies employed in the manufacture of MDIs

include:

Use of a vapor return hose

Vapor return hoses minimize emissions during the transfer of CFCs from
tank trucks to on-site storage tanks.  These hoses ensure that CFC vapor
from the top of the storage tank flows back into the delivery vehicle
rather than being vented to the atmosphere.

Trucks and canisters dedicated to a single material

Delivery trucks and canisters are dedicated to a single type of
material.  Refilling of a truck or canister results in reduced emissions
through emission-controlled sampling and testing of the refilled truck
or canister for quality and purity of the CFC.  The need to vent and
clean multiple-use trucks and canisters is eliminated, thereby
decreasing associated emissions.

Installation of permanent, hard piping

Temporary, flexible hosing for CFC transfer is replaced with permanent,
hard piping.  The piping reduces CFC vapor emission because it does not
need to be drained, disconnected, or vented between runs.

Detection and prevention of pump failure

Electronic sensors and automatic valves are installed in order to close
off and isolate a pump in the event of pump failure.  Listening devices
are also installed to detect imminent pump failure.

Detection and prevention of leaks

Inspection and maintenance programs are employed to minimize the risk
of, and promptly detect and remedy, leaks in transfer networks.

Minimization of mixing vessel waste material

The blending of CFCs and pharmaceutical active ingredient(s) results in
an extremely small amount of CFC-containing waste material.  A process
has been developed to minimize this waste product.

Destruction or reclamation of CFC-containing waste material

CFC-containing waste material from blending and cleaning operations is
destroyed.  The possibility of reclaiming the CFCs in this waste
material is being explored.

Minimization of leaks during blending

Seals on blending vessels have been redesigned and improved to minimize
emissions during the formulation blending process.  Hermetically sealed
vessels are drained and cleaned without venting to the environment.
Programs are in place to check for leaks during the blending process.

Replacement of rubber elastomers in MDIs

New elastomers have been employed to reduce the number of rejected lots
and the leak rate of MDIs.

In-line stainless steel filters

CFC filters are used more efficiently and replaced less frequently,
thereby reducing the release of CFCs during each filter change.

Special gassing adapters

Gassing adapters specially designed for the MDI minimize the release of
propellant during the filling of each MDI canister.

Use of CFC-free solvents

CFC-free solvents are used for many elements of the cleaning process.

10.   Describe the steps being taken to provide a continuity of supply
of asthma and chronic obstructive pulmonary disease treatments to
importing non-Article 5(l) countries, Article 5(l) countries and CEIT.
Also describe the steps being taken by companies to assist their MDI
manufacturing facilities in Parties operating under Article 5(l) and
CEIT in upgrading the technology and capital equipment needed for
manufacturing non-CFC asthma and chronic obstructive pulmonary disease
treatments.  (Decision VIII/10, pars. 9 and 10)

Many U.S. pharmaceutical companies have a multinational presence, and
have introduced CFC-free alternatives in other countries.  As
reformulation programs are completed, and necessary regulatory approvals
secured, CFC-free alternatives will be introduced in both domestic and
export markets.

III	Substantiation of Volumes

1.	Please indicate below the actual or estimated quantities of CFCs used
in years prior to the first year for which an exemption is requested.

		CFCs Used for MDIs Prior to Nomination (metric tonnes)

Ozone Depleting Substance 	1993	1994	1995

CFC-l1, 12, 113, 114 (aggregate)

2981.55

3044.61

3300.2

	Data for years 1995-2006 are provided in the U.S. Reporting Accounting
Framework for Essential Uses which is provided to the Secretariat on an
annual 	basis.

2.	For the nominated quantities intended for use in MDIs for export,
assure that the Secretariat's list of CFC MDI active ingredients and/or
category of products determined to be non-essential by an importing
Party has been consulted, and that none of the volumes requested shall
be used for items posted on that list.

No nominated quantities will be used for a product determined to be
non-essential by an importing Party.

3.	Provide details of the management of the stockpile and any surplus.
(Decision IV/25, par. 1(b)(ii))

The USFDA examines data on holdings of CFCs and recommends adjustments
to the amounts nominated and to the amounts subsequently allocated to
reflect the need for a cushion of a one year operational supply.  The
Montreal Protocol's Technology and Economic Assessment Panel (TEAP) has
recommended a 12-month level of reserves as reasonable to guard against
unforeseen events.  Decision XVI/12, taken by the Parties at their
Sixteenth Meeting in November 2004, instructed nominating countries to
“give due consideration to existing stocks, whether owned or agreed to
be acquired from a metered-dose inhaler manufacturer, of banked or
recycled controlled substances as described in paragraph 1(b) of
decision IV/25, with the objective of maintaining no more than one
year’s operational supply.”  Any amounts nominated by the Party
reflect the level of essential need in accordance with Decision XVI/12
taking into account the availability of recycled and stockpiled ODS.
The calculation of a one year’s operational supply includes both
pre-1996 CFCs and essential use CFCs.

4.	Provide details of the existing stock of pharmaceutical-grade CFCs
(pre- and post-1996) held by the Party requesting an essential use
exemption, describing the quantity (metric tonnes), the quality and 	the
availability for the year prior to the nomination.  Describe how 	this
stockpile will be utilised in coming years.  (Decision IV/25, par.
1(b)(ii) and Decision XVI/12, par. 3)

	Data on aggregate stocks of CFCs held by MDI companies will be provided
with the 2005 accounting framework under separate cover.

5.	Confirm that the nominating Party has given due consideration to 	the
following.  That:

	a.	Each company's existing stock of pharmaceutical-grade CFCs
(including CFCs the company possesses or has title to, pre- and post-
1996) aims not to exceed one year's operational supply (the amount used
by the company to produce CFC MDIs in the preceding year);

	b.	The Party's aggregate stocks of pharmaceutical-grade CFCs (pre- and
post-1996) aim not to exceed one year's operational supply for that
Party;

	c.	The Party’s nomination has been reduced, if necessary, with the
objective of the Party’s aggregate stocks of available pre- and
post-1996 pharmaceutical-grade CFCs not exceeding one year’s
operational supply; and

	d.	All available pre-1996 stockpiles have been, or will be, depleted by
companies before drawing on essential use quantities and thereby assure
that pre-1996 stockpiles are taken into account in making essential use
requests.

		(Decision IV/25, par. 1(b)(ii) and Decision XVI/12, par. 3)

A description of the how the United States treats stocks is provided
above.  The United States aims to ensure no more than a one year
operational supply of stocks (aggregate pre and post 1996) available to
MDI companies and makes reductions to the amount of CFCs nominated and
allocated to reflect this calculation in accordance with the language in
Decision IX/6 and related decisions.

IV. Reporting Accounting Framework for Essential Uses Other than
Laboratory and Analytical Applications

Accounting framework to be forwarded to the Ozone Secretariat under
separate cover after January 31, 2006.

 	The Parties decided in Decision X/6 to approve CFCs in the aggregate
rather than by individual compound.  Therefore, Parties need only
provide the total requested quantity of CFC-11, CFC-12, CFC-113, and/or
CFC-114 in the aggregate.

 	"Use of Ozone-Depleting Substances; Essential-Use Determinations." 67
Federal Register 48370.

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[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Notices]
[Pages 8208-8210]
[FR Doc No: 2014-02933]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30908; File No. 812-14211]

The Gabelli Dividend & Income Trust, et al.; Notice of
Application

February 6, 2014.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 17(b) of the Investment
Company Act of 1940 (the ``Act'') requesting an exemption from section
17(a) of the Act, and for an order under section 17(d) of the Act and
rule 17d-1 thereunder permitting certain joint transactions.

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    Applicants: The Gabelli Dividend & Income Trust (``Dividend
Trust''), The Gabelli Global Small and Mid Cap Value Trust (``Global
Trust'') (each, a ``Fund'' and together, the ``Funds'') and Gabelli
Funds, LLC (the ``Adviser'').
SUMMARY: Summary of Application: Applicants seek an order to permit
Dividend Trust to transfer a segment of its assets to Global Trust, a
newly formed, wholly-owned subsidiary that is a registered closed-end
investment company, and to distribute the shares of Global Trust common
stock to the holders of Dividend Trust's common stock.

DATES: Filing Dates: The application was filed on September 11, 2013
and amended on January 28, 2014.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on February 27, 2014 and should be accompanied by proof of
service on the applicants, in the form of an affidavit, or, for
lawyers, a certificate of service. Hearing requests should state the
nature of the writer's interest, the reason for the request, and the
issues contested. Persons who wish to be notified of a hearing may
request notification by writing to the Commission's Secretary.

ADDRESS: Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE., Washington, DC, 20549-1090; Applicants:
Richard T. Prins, Esq., Skadden, Arps, Slate, Meagher & Flom LLP, Four
Times Square, New York, New York 10036.

FOR FURTHER INFORMATION CONTACT:  Laura J. Riegel, Senior Counsel, at
(202) 551-6873 or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:  The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. Dividend Trust, a Delaware statutory trust, is registered under
the Act as a diversified closed-end management investment company.
Dividend Trust seeks to provide a high level of total return on its
assets with an emphasis on dividends and income. Under normal market
conditions, Dividend Trust invests at least 80% of its assets in
dividend-paying securities or other income-producing securities, and at
least 50% of its assets in dividend-paying equity securities. Dividend
Trust has a non-fundamental policy that limits investment in securities
of non-United States issuers to 35% of its total assets.
    2. Global Trust was organized as a Delaware statutory trust on
August 19, 2013 and is wholly-owned by Dividend Trust. Global Trust
filed a notification of registration on Form N-8A on September 11, 2013
to register under the Act as a diversified closed-end management
investment company. Global Trust filed a registration statement under
the Securities Act of 1933 (the ``1933 Act'') on Form N-14 on September
11, 2013 (the ``Proxy Statement/Prospectus'') and filed a registration
statement on Form N-2 on December 10, 2013. Application will be made to
list Global Trust's common shares for trading on the New York Stock
Exchange. Global Trust seeks to provide long-term capital growth. Under
normal market conditions, Global Trust will invest at least 40% of its
total assets in the equity securities of companies located outside the
United States and in at least three countries. Unlike Dividend Trust,
Global Trust may invest without limitation in the equity securities of
companies located outside the United States.
    3. The Adviser, a New York limited liability company, is registered
under the Investment Advisers Act of 1940. The Adviser serves, or will
serve, respectively, as the investment adviser to Dividend Trust and
Global Trust. Applicants represent that the investment advisory fee
structure for Global Trust will be the same as the advisory fee
structure for Dividend Trust.
    4. The board of trustees of Dividend Trust consists of ten
trustees, five of whom are also trustees of the six member board of
trustees of Global Trust (each such board of trustees, a ``Board'' and
collectively, the ``Boards''). Seven trustees on the Board of Dividend
Trust are not ``interested persons,'' as defined in section 2(a)(19) of
the Act (the ``Independent Trustees''), and five trustees on the Board
of Global Trust are Independent Trustees. The President and the
Treasurer of Dividend Trust hold the same offices with Global Trust.
    5. The Board of Dividend Trust has approved, subject to the
issuance of the requested relief and subsequent shareholder approval,
the contribution of a segment of Dividend Trust's assets having a value
of approximately $100 million to Global Trust, in exchange for

shares of Global Trust common stock. It is anticipated that the
contributed assets will consist largely or exclusively of cash and
short-term fixed income instruments. All the shares of common stock of
Global Trust will then be distributed by Dividend Trust as a dividend
to its common shareholders at an anticipated rate of one (1) share of
Global Trust common stock for every ten (10) shares held of Dividend
Trust common stock.\1\ The contribution of the Dividend Trust assets to
Global Trust and the subsequent distribution of shares of Global Trust
common stock to Dividend Trust common shareholders are referred to as
the ``Transaction.'' \2\
---------------------------------------------------------------------------

    \1\ This estimate is based on the number of Dividend Trust
common shares outstanding as of December 31, 2013 and a target
initial net asset value per share of Global Trust common stock of
$12.00.
    \2\ No fractional shares of Global Trust common stock will be
issued as part of the Transaction. The fractional shares to which
holders of Dividend Trust common stock would otherwise be entitled
will be aggregated and an attempt to sell them in the open market
will be made at then-prevailing prices on behalf of such holders,
and such holders will receive instead a cash payment in the amount
of their pro rata share of the total sales proceeds.
---------------------------------------------------------------------------

    6. The Proxy Statement/Prospectus of the Funds will be used,
following the issuance of the requested relief, to solicit approval of
the Dividend Trust shareholders of the Transaction. Prior to the
effectiveness of the Proxy Statement/Prospectus under the 1933 Act,
Dividend Trust will purchase shares of Global Trust's common stock in
consideration of Dividend Trust's contribution to Global Trust of at
least $100,000 initial net asset value (the ``Seed Capital Shares''),
in order to satisfy the requirements of section 14(a) of the Act.
Applicants intend that the Seed Capital Shares will be included in the
distribution of Global Trust's shares of common stock to the common
shareholders of Dividend Trust, and, accordingly, will be sold pursuant
to a registration statement under the 1933 Act.
    7. The Board of Dividend Trust, including all the Independent
Trustees, concluded that the Transaction will result in the following
benefits to Dividend Trust common shareholders: (a) shareholders will
receive shares of an investment company with a different risk-return
profile than Dividend Trust; (b) shareholders will acquire the shares
of Global Trust common stock at a much lower transaction cost than is
typically the case for a newly-organized closed-end equity fund since
there will be no underwriting discounts or commissions; and (c)
shareholders will be afforded the opportunity to seek the capital
growth opportunities presented by substantial foreign securities
exposure.
    8. The Board of Dividend Trust has been advised by counsel that the
distribution of common shares of Global Trust to the common
shareholders of Dividend Trust likely will be a taxable event for
Dividend Trust common shareholders to some extent and, under certain
circumstances, also will be a taxable event for Dividend Trust.
Dividend Trust does not expect that it will recognize significant
taxable gain on its distribution of Global Trust common shares because
it does not expect any of the contributed short-term debt securities to
have a value at the time of their contribution to Global Trust
significantly in excess of Dividend Trust's tax basis for those
securities. Further, the Transaction is not expected to increase
significantly the total amount of taxable distributions received by
Dividend Trust common shareholders for the year in which the
Transaction is consummated because Dividend Trust has adopted a policy
of distributing to shareholders monthly substantially all of its
taxable income and, accordingly, any taxable income included in the
distribution of Global Trust common shares would be distributed at some
point during the year. The Board of Dividend Trust, including all of
the Independent Trustees, has considered the tax consequences of the
Transaction and has determined that the benefits of the Transaction
outweigh any adverse tax consequences to Dividend Trust and its common
shareholders, particularly because such adverse tax consequences are
expected to be minimal.
    9. The costs of organizing Global Trust and effecting the
distribution of Global Trust's shares to Dividend Trust's common
shareholders, including the fees and expenses of counsel and
accountants and printing, listing and registration fees, the costs of
soliciting shareholder approval of the Transaction, and the costs
incurred in connection with the application for relief, are estimated
to be approximately $750,000, and will be borne by Dividend Trust.
Global Trust will incur operating expenses on an ongoing basis,
including legal, auditing, transfer agency, and custodian expenses
that, when aggregated with the fees payable by Dividend Trust for
similar services after the distribution, will likely exceed the fees
and expenses currently payable by Dividend Trust for those services.
The Board of Dividend Trust, including all of the Independent Trustees,
concluded that it is appropriate for Dividend Trust to bear the
Transaction's costs inasmuch as the benefits of the Transaction will be
for Dividend Trust's common shareholders and because absorption of such
expenses will eliminate any deficit in the net asset value of Global
Trust common shares in comparison to the amount of the distribution,
which may support the pricing of Global Trust common shares in trading
on the New York Stock Exchange. It is not expected that the Transaction
will have a significant effect on the annual expenses of Dividend Trust
as a percentage of its assets.

Applicants' Legal Analysis

    1. Applicants request an order under section 17(b) of the Act
granting an exemption from section 17(a) of the Act and under section
17(d) of the Act and rule 17d-1 thereunder permitting certain joint
transactions.
    2. Section 17(a) of the Act generally prohibits sales or purchases
of securities between a registered investment company and an affiliated
person. Section 2(a)(3) of the Act defines an ``affiliated person'' of
another person to include (a) any person directly or indirectly owning,
controlling, or holding with power to vote 5% or more of the
outstanding voting securities of the other person, (b) any person 5% or
more of whose voting securities are directly or indirectly owned
controlled or held with the power to vote by the other person, and (c)
any person directly or indirectly controlling, controlled by, or under
common control with, the other person. Dividend Trust may be viewed as
an affiliated person of Global Trust under section 2(a)(3) because
Dividend Trust will own 100 percent of the Global Trust's voting
securities until the consummation of the Transaction. Dividend Trust
and Global Trust also may be viewed as affiliated persons of each other
to the extent that they may be deemed to be under the common control of
the Adviser. As a result of the affiliation between Dividend Trust and
Global Trust, section 17(a) would prohibit the Transaction.
    3. Applicants request an exemption pursuant to section 17(b) of the
Act from the provisions of section 17(a) in order to permit applicants
to effect the Transaction. Section 17(b) authorizes the Commission to
issue such an exemptive order if the Commission finds that the terms of
the proposed transaction are fair and reasonable and do not involve
overreaching on the part of any persons concerned, and the proposed
transaction is consistent with the policy of each registered investment
company and the general purposes of the Act.
    4. Applicants assert that the terms of the Transaction, including
the

consideration to be paid or received, are fair and reasonable and do
not involve overreaching by any person concerned. Applicants state that
the proposed contribution by Dividend Trust of a portion of its assets
to Global Trust in exchange for shares of Global Trust common stock
will be based on the fair value of such assets computed as of the close
of trading on the New York State Exchange on a business day to be
selected by the Board of Dividend Trust (such business day, the
``Valuation Date''), in the same manner as for purposes of the daily
net asset valuation for Dividend Trust. The Transaction will occur
after the close of trading on the New York Stock Exchange on the
Valuation Date. Applicants anticipate that such assets will consist
largely or exclusively of cash and short-term fixed income instruments
and thus will pose no issues with respect to valuation. Shares of
Global Trust common stock distributed by Dividend Trust in the
Transaction will be valued based on the value of Global Trust's assets.
``Value'' for those purposes will be determined in accordance with the
provisions of section 2(a)(41) of the Act and rule 2a-4 under the Act.
    5. With respect to the Transaction, each Board, including a
majority of the Independent Trustees, determined that participation in
the Transaction is in the best interests of Dividend Trust or Global
Trust, as applicable, and that the interests of the existing
shareholders of Dividend Trust or Global Trust, as applicable, will not
be diluted as a result of the Transaction. These findings, and the
basis upon which the findings were made, will be recorded fully in the
minute book of Dividend Trust or Global Trust, as applicable.
    6. Applicants state that the Transaction will be consistent with
the stated investment policies of Dividend Trust and Global Trust as
disclosed to shareholders. The distribution of shares of Global Trust
common stock will not initially change the position of Dividend Trust's
shareholders with respect to the underlying investments that they then
own. The Proxy Statement/Prospectus will be used to solicit the
approval of Dividend Trust's shareholders of the Transaction at a vote
to take place following the issuance of the requested order. Dividend
Trust's shareholders will have the opportunity to vote on the
Transaction after having received disclosure concerning the
Transaction.
    7. Applicants also seek an order under section 17(d) of the Act and
rule 17d-1 under the Act. Section 17(d) and rule 17d-1 prohibit
affiliated persons from participating in joint arrangements with a
registered investment company unless authorized by the Commission. In
passing on applications for these orders, rule 17d-1 provides that the
Commission will consider whether the participation of the investment
company is consistent with the provisions, policies and purposes of the
Act, and the extent to which the participation is on a basis different
from or less advantageous than that of the other participants.
Applicants request an order pursuant to rule 17d-1 to the extent that
the participation of applicants in the Transaction may be deemed to
constitute a prohibited joint transaction.
    8. Applicants state that the Transaction will not place any of
Dividend Trust, Global Trust, or existing shareholders of Dividend
Trust in a position less advantageous than that of any other person.
The value of Dividend Trust's assets transferred to Global Trust (and
the shares of Global Trust common stock received in return) will be
based on the fair value of such assets computed as of the close of
trading on the New York Stock Exchange on the Valuation Date in
accordance with the requirements of the Act and pursuant to valuation
procedures adopted by the Board of Dividend Trust. The shares of Global
Trust common stock will be distributed to Dividend Trust's common
shareholders, leaving the shareholders in the same investment posture
immediately following the Transaction as before, subject only to
changes in market price of the underlying assets subsequent to the
Transaction.
    9. Applicants assert that the Transaction has been proposed in
order to benefit the shareholders of Dividend Trust as well as Global
Trust. Applicants state that neither the Adviser nor any other
affiliated person of Dividend Trust or Global Trust will receive
additional fees solely as a result of the Transaction. In addition,
applicants state that although it is possible that the creation of
Global Trust may benefit the Adviser by providing it with an additional
managed fund, the Board of Dividend Trust has determined that such
result does not supply a benefit that could not have otherwise been
achieved through an initial public offering of a global equity
securities fund and that such benefit is both marginal and hypothetical
because the assets of Dividend Trust to be contributed to Global Trust
pursuant to the Transaction represent only approximately 5.0% of
Dividend Trust's net assets as of December 31, 2013. In addition, by
creating Global Trust through the Transaction, Dividend Trust is
effectively enabling its common shareholders to receive securities
without the costs associated with a public offering.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-02933 Filed 2-10-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Rules and Regulations]
[Pages 38484-38486]
[FR Doc No: 2012-15816]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0380]

Safety Zones; Annual Fireworks Events in the Captain of the Port
Detroit Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce various safety zones for annual
fireworks events in the Captain of the Port Detroit zone from 9:30 p.m.
on June 18, 2012 through 11:59 p.m. on September 2, 2012. This action
is necessary and intended to ensure safety of life on the navigable
waters immediately prior to, during, and immediately after fireworks
events. During the aforementioned period, the Coast Guard will enforce
restrictions upon, and control movement of, vessels in a specified area
immediately prior to, during, and immediately after fireworks events.
During each enforcement period, no person or vessel may enter the
respective safety zone without permission of the Captain of the Port.

DATES: The regulations in 33 CFR 165.941 will be enforced at various
times between 9:30 p.m. on June 18, 2012 through 11:59 p.m. on
September 2, 2012.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email LT Adrian Palomeque, Prevention, U.S. Coast Guard Sector
Detroit, 110 Mount Elliot Ave., Detroit MI, 48207; telephone (313) 568-
9508, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones listed in 33 CFR 165.941, Safety Zones; Annual Fireworks Events
in the Captain of the Port Detroit Zone, at the following dates and
times for the following events:
    (1) Bay-Rama Fishfly Festival Fireworks, New Baltimore, MI.
    The safety zone listed in 33 CFR 165.941(a)(30) will be enforced
from 9:00 p.m. to 11:00 p.m. on June 21, 2012. In the case of inclement
weather on June 21, 2012, this safety zone will be enforced from 9:00
p.m. to 11:00 p.m. on June 22, 2012. In the case of inclement weather
on June 22, 2012, this safety zone will be enforced from 9:00 p.m. to
11:00 p.m. on June 23, 2012.
    (2) St. Clair Shores Fireworks, St. Clair Shores, MI.
    The safety zone listed in 33 CFR 165.941(a)(40) will be enforced
from 10:00 p.m. to 10:30 p.m. on June 29, 2012. In the case of
inclement weather on June 29, 2012, this safety zone will be enforced
from 10:00 p.m. to 10:30 p.m. on June 30, 2012.
    (3) Target Fireworks, Detroit, MI.
    The first safety zone listed in 33 CFR 165.941(a)(51) will not be
enforced.
    The second safety zone listed in 33 CFR 165.941(a)(51) will be
enforced from 8:00 p.m. to 11:55 p.m. on June 25, 2012. In the case of
inclement weather on June 25, 2012, the second safety zone will be
enforced from 8:00 p.m. to 11:55 p.m. on June 26, 2012.
    The third safety zone listed in 33 CFR 165.941(a)(51) will be
enforced from 6:00 p.m. to 11:55 p.m. on June 25, 2012. In the case of
inclement weather on June 25, 2012, the third safety zone will be
enforced from 6:00 p.m. to 11:55 p.m. on June 26, 2012.
    (4) Sigma Gamma Fireworks, Grosse Pointe Farms, MI.
    The safety zone listed in 33 CFR 165.941(a)(52) will be enforced
from 9:30 p.m. to 10:00 p.m. on June 18, 2012.
    (5) Harrisville Fireworks, Harrisville, MI.
    The safety zone listed in 33 CFR 165.941(a)(8) will be enforced
from 9:30 p.m. to 11:30 p.m. on July 7, 2012. In the case of inclement
weather on July 7, 2012, this safety zone will be enforced from 9:30
p.m. to 11:30 p.m. on July 8, 2012.
    (6) Au Gres City Fireworks, Au Gres, MI.
    The safety zone listed in 33 CFR 165.941(a)(3) will be enforced
from 10:00 p.m. to 10:30 p.m. on June 30, 2012. In the case of
inclement weather on June 30, 2012, this safety zone will be enforced
from 10:00 p.m. to 10:30 p.m. on July 1, 2012.
    (7) Caseville Fireworks, Caseville, MI.
    The safety zone listed in 33 CFR 165.941(a)(37) will be enforced
from 10:00 p.m. to 11:00 p.m. on July 3, 2012. In the case of inclement
weather on July 3, 2012, this safety zone will be enforced from 10:00
p.m. to 11:00 p.m. on July 5, 2012.
    (8) Grosse Isle Yacht Club Fireworks, Grosse Isle, MI.
    The safety zone listed in 33 CFR 165.941(a)(45) will be enforced
from 9:45 p.m. to 10:45 p.m. on July 3, 2012. In the case of inclement
weather on July 3, 2012, this safety zone will be enforced from 9:45
p.m. to 10:45 p.m. on July 4, 2012.
    (9) Lexington Independence Festival Fireworks, Lexington, MI.
    The safety zone listed in 33 CFR 165.941(a)(43) will be enforced
from 10:00 p.m. to 10:30 p.m. on June 30, 2012. In the case of
inclement weather on June 30, 2012, this safety zone will be enforced
from 10:00 p.m. to 10:30 p.m. on July 1, 2012.
    (10) Algonac Pickerel Tournament Fireworks, Algonac, MI.
    The safety zone listed in 33 CFR 165.941(a)(38) will be enforced
from 10:00 p.m. to 10:30 p.m. on June 30, 2012. In the case of
inclement weather on June 30, 2012, this safety zone will be enforced
from 10:00 p.m. to 10:30 p.m. on July 3, 2012.
    (11) Grosse Pointe Farms Fireworks, Grosse Pointe Farms, MI.
    The safety zone listed in 33 CFR 165.941(a)(36) will be enforced
from 10:00 p.m. to 10:30 p.m. on June 30, 2012. In the case of
inclement weather on June 30, 2012, this safety zone will be enforced
from 10:00 p.m. to 10:30 p.m. on July 1, 2012.
    (12) Belle Maer Harbor 4th of July Fireworks, Harrison Township,
MI.
    The safety zone listed in 33 CFR 165.941(a)(47) will be enforced
from 10:00 p.m. to 10:30 p.m. on July 4, 2012. In the case of inclement
weather on July 4, 2012, this safety zone will be enforced from 10:00
p.m. to 10:30 p.m. on July 5, 2012.
    (13) City of St. Clair Fireworks, St. Clair, MI.
    The safety zone listed in 33 CFR 165.941(a)(32) will be enforced
from 10:00 p.m. to 10:20 p.m. on July 4, 2012. In the case of inclement
weather on July 4, 2012, this safety zone will be enforced from 10:00
p.m. to 10:20 p.m. on July 5, 2012.
    (14) Port Austin Fireworks, Port Austin, MI.
    The safety zone listed in 33 CFR 165.941(a)(34) will be enforced
from 10:00 p.m. to 10:30 p.m. on July 4, 2012. In the case of inclement
weather on July 4, 2012, this safety zone will be enforced from 10:00
p.m. to 10:30 p.m. on July 5, 2012.
    (15) Trenton Fireworks, Trenton, MI.
    The safety zone listed in 33 CFR 165.941(a)(46) will be enforced
from 10:00 p.m. to 10:30 p.m. on July 4, 2012. In the case of inclement
weather on July 4, 2012, this safety zone will be enforced from 10:00
p.m. to 10:30 p.m. on July 5, 2012.
    (16) Grosse Pointe Yacht Club 4th of July Fireworks, Grosse Pointe
Shores, MI.
    The safety zone listed in 33 CFR 165.941(a)(42) will be enforced
from 10:00 p.m. to 10:30 p.m. on July 4, 2012. In the case of inclement
weather on July 4, 2012, this safety zone will be enforced from 10:00
p.m. to 10:30 p.m. on July 5, 2012.
    (17) Trenton Rotary Roar on the River Fireworks, Trenton, MI.
    The safety zone listed in 33 CFR 165.941(a)(10) will be enforced
from 10:00 p.m. until 11:00 p.m. on July 20, 2012. In the case of
inclement weather on July 20, 2012, this safety zone will be enforced
from 10:00 p.m. until 11:00 p.m. on July 21, 2012.
    (18) Marine City Maritime Festival Fireworks, Marine City, MI.
    The safety zone listed in 33 CFR 165.941(a)(14) will be enforced
from 10:00 p.m. until 10:20 p.m. on August 10, 2012. In the case of
inclement weather on August 10, 2012, this safety

zone will be enforced from 10:00 p.m. until 10:20 p.m. on August 11,
2012.
    (19) Detroit International Jazz Festival Fireworks, Detroit, MI.
    The safety zone listed in 33 CFR 165.941(a)(13) will be enforced
from 10:00 p.m. to 11:59 p.m. on September 1, 2012. In the case of
inclement weather on September 1, 2012, this safety zone will be
enforced from 10:00 p.m. to 11:59 p.m. on September 2, 2012. In the
case of inclement weather on September 2, 2012, this safety zone will
be enforced from 10:00 p.m. to 11:59 p.m. on September 3, 2012.
    (20) Port Sanilac 4th of July Fireworks, Port Sanilac, MI.
    The safety zone listed in 33 CFR 165.941(a)(39) will be enforced
from 10:00 p.m. to 11:00 p.m. on July 7, 2012. In the case of inclement
weather on July 7, 2012, this regulation will be enforced from 10:00
p.m. to 11:00 p.m. on July 8, 2012.
    (21) Tawas City 4th of July Fireworks, Tawas City, MI.
    The safety zone listed in 33 CFR 165.941(a)(48) will be enforced
from 10:00 p.m. to 11:00 p.m. on July 4, 2012. In the case of inclement
weather on July 4, 2012, this regulation will be enforced from 10:00
p.m. to 11:00 p.m. on July 5, 2012.
    (22) Roostertail Fireworks (barge), Detroit, MI.
    The safety zone listed in 33 CFR 165.941 (a)(1) will be enforced
from 10:00 p.m. to 10:30 p.m. on June 22, 2012.
    (23) The Old Club Fireworks, Harsens Island, MI.
    The safety zone listed in 33 CFR 165.941 (a)(4) will be enforced
from 10:00 p.m. to 10:20 p.m. on June 30, 2012. In the case of
inclement weather on June 30, 2012, this regulation will be enforced
from 10:00 p.m. to 10:20 p.m. on July 7, 2012.
    Under the provisions of 33 CFR 165.23, entry into, transiting, or
anchoring within anyone of these safety zones during the enforcement
period is prohibited unless authorized by the Captain of the Port
Detroit or his designated representative. Vessels that wish to transit
through the safety zones may request permission from the Captain of the
Port Detroit. Requests must be made in advance and approved by the
Captain of Port before transits will be authorized. Approvals will be
granted on a case by case basis. The Captain of the Port may be
contacted via U.S. Coast Guard Sector Detroit on channel 16, VHF-FM.
The Coast Guard will give notice to the public via Local Notice to
Mariners and VHF radio broadcasts that the regulation is in effect.
    This notice is issued under authority of 33 CFR 165.23 and 5 U.S.C.
552(a). If the Captain of the Port determines that any of these safety
zones need not be enforced for the full duration stated in this notice,
he or she may use a Broadcast Notice to Mariners to grant general
permission to enter the safety zone.

    Dated: June 13, 2012.
J.E. Ogden,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2012-15816 Filed 6-27-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Page 13179]
[FR Doc No: 2011-5493]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

------------------------------------------------------------------------
             Docket No.               File date   Presenter or requester
------------------------------------------------------------------------
Prohibited:
    1. ER03-329-010 and ER07-597-        2-22-11  Alfred Corbett.\1\
     005.
Exempt:
    1. Project No. 13123-002.......      2-24-11   LaShavio Johnson.
    2. CP11-46-000.................       3-3-11  Melanie Stalder.\2\
------------------------------------------------------------------------
\1\ Memo to file regarding telephone call from representatives of
  NorthWestern Corporation.
\2\ Record of e-mail correspondence.

    Dated: March 3, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-5493 Filed 3-9-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Rules and Regulations]
[Pages 39970-39973]
[FR Doc No: 2015-17055]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R04-OAR-2014-0870; FRL-9930-49-Region 4]

Approval and Promulgation of Implementation Plans and Designation
of Areas for Air Quality Planning Purposes; Tennessee; Redesignation of
the Knoxville 2008 8-Hour Ozone Nonattainment Area to Attainment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking four
separate final actions related to a state implementation plan (SIP)
revision submitted by the State of Tennessee, through the Tennessee
Department of Environment and Conservation (TDEC), Division of Air
Pollution Control, on November 14, 2014, for the Knoxville, Tennessee
8-hour ozone nonattainment area (hereinafter referred to as the
``Knoxville Area'' or ``Area''). The Knoxville Area includes a portion
of Anderson County as well as Blount and Knox Counties in their
entireties. EPA is approving the base year emissions inventory for the
2008 8-hour ozone national ambient air quality standards (NAAQS) for
the Knoxville Area; determining that the Knoxville Area is attaining
the 2008 8-hour ozone NAAQS; approving into the SIP the State's plan
for maintaining attainment of the 2008 8-hour ozone NAAQS in the Area,
including the 2011 and 2026 motor vehicle emission budgets (MVEBs) for
nitrogen oxides (NOX) and volatile organic compounds (VOC);
and redesignating the Area to attainment for the 2008 8-hour ozone
NAAQS. EPA is also finding the 2011 and 2026 MVEBs for NOX
and VOC for the Knoxville Area adequate for the purposes of
transportation conformity.

DATES: This rule is effective August 12, 2015.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2014-0870. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section (formerly the Regulatory
Development Section), Air Planning and Implementation Branch (formerly
the Air Planning Branch), Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jane Spann or Tiereny Bell of the Air
Regulatory Management Section, in the Air Planning and Implementation
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. Ms. Spann may be reached by phone at (404)
562-9029 or via electronic mail at<EMAIL_ADDRESS>Ms. Bell may be
reached by phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background for Final Actions

    On May 21, 2012, EPA designated areas as unclassifiable/attainment
or nonattainment for the 2008 8-hour ozone NAAQS that was promulgated
on March 27, 2008. See 77 FR 30088. The Knoxville Area was designated
as nonattainment for the 2008 8-hour ozone NAAQS and classified as a
marginal nonattainment area. On November 14, 2014, TDEC requested that
EPA redesignate the Area to attainment for the 2008 8-hour ozone NAAQS
and submitted a SIP revision containing a base year emissions inventory
for the Area to address the requirements of Clean Air Act (CAA or Act)
section 182(a)(1) and the State's plan for maintaining attainment of
the 2008 8-hour ozone standard in the Area, including the 2011 and 2026
MVEBs for NOX and VOC. In a notice of proposed rulemaking
(NPR) published on May 21, 2015, EPA proposed to approve the base year
emissions inventory for the 2008 8-hour ozone NAAQS for the Knoxville
Area; to determine that the Knoxville Area is attaining the 2008 8-hour
ozone NAAQS; to approve into the SIP the

State's plan for maintaining attainment of the 2008 8-hour ozone
standard in the Area, including the 2011 and 2026 MVEBs for
NOX and VOC; and to redesignate the Area to attainment for
the 2008 8-hour ozone NAAQS. See 80 FR 29237. In that notice, EPA also
notified the public of the status of the Agency's adequacy
determination for the Knoxville Area NOX and VOC MVEBs.\1\
The details of Tennessee's submittal and the rationale for EPA's
actions are explained in the NPR. EPA received one comment on the May
21, 2015, NPR. This comment is provided in the docket for today's final
actions and supports those actions. EPA's response to the comment is
provided below.
---------------------------------------------------------------------------

    \1\ Tennessee's November 14, 2015, SIP submission, including the
Knoxville Area NOX and VOC MVEBs, was open for public
comment on EPA's adequacy Web site on December 4, 2014, found at:
http://www.epa.gov/otaq/stateresources/transconf/currsips.htm#knx-tn. The EPA public comment period on adequacy for the MVEBs for 2011
and 2026 for the Knoxville Area closed on January 5, 2015. No
comments, adverse or otherwise, were received during EPA's adequacy
process for the MVEBs associated with Tennessee's maintenance plan.
---------------------------------------------------------------------------

II. EPA's Response to Comment

    The Commenter ``support[s] this docket as written'' and states that
``it is clear the metro area [Knoxville] is in attainment of the 2008
8-hour ozone standard.'' Although supportive of the actions, the
Commenter is ``somewhat suspicious of the large projected decreases in
NOX from [on] road sources, given that vehicle traffic will
almost certainly be increasing throughout the modeled time period.''
The Commenter believes that it ``seems likely that smaller. .
.reductions in NOX from [on] road sources. . . will still
result in continued attainment of the ozone standard given that current
NOX emissions are resulting in ozone attainment.''
    EPA does not view this comment as adverse. Regarding the magnitude
of the projected on-road mobile source NOX emissions
reductions given increased vehicle traffic, EPA notes that Tennessee
used the interagency consultation process required by 40 CFR part 93
(known as the Transportation Conformity Rule) which requires EPA, the
United States Department of Transportation, metropolitan planning
organizations (MPOs), state departments of transportation, and State
and local air quality agencies to work together to develop applicable
implementation plans. The planning assumptions used to develop on-road
NOX emissions estimates for the Knoxville Area maintenance
plan applied emissions factors developed from the latest EPA-approved
mobile emissions model (known as the Motor Vehicle Emissions Simulator
or MOVES2014) and did consider increased vehicle traffic by
incorporating the increased vehicle miles travelled from the MPO's
travel demand model. MOVES2014 is the state-of-the-science emissions
model that incorporates the newest emissions control regulatory
programs.

III. What are the effects of these actions?

    Approval of Tennessee's redesignation request changes the legal
designation of Blount and Knox Counties and the portion of Anderson
County included in the Knoxville Area, found at 40 CFR 81.343, from
nonattainment to attainment for the 2008 8-hour ozone NAAQS. Approval
of Tennessee's associated SIP revision also incorporates a plan for
maintaining the 2008 8-hour ozone NAAQS in the Knoxville Area through
2026 and a section 182(a)(1) base year emissions inventory into the
Tennessee SIP. The maintenance plan establishes NOX and VOC
MVEBs for 2011 and 2026 for the Knoxville Area and includes contingency
measures to remedy any future violations of the 2008 8-hour ozone NAAQS
and procedures for evaluation of potential violations. The
NOX MVEBs for 2011 and 2026 are 41.62 tons per day (tpd) and
17.69 tpd, respectively. The VOC MVEBs for 2011 and 2026 are 19.71 tpd
and 10.49 tpd, respectively. Additionally, EPA is finding the newly-
established NOX and VOC MVEBs for the Knoxville Area
adequate for the purpose of transportation conformity. Within 24 months
from this final rule, the transportation partners will need to
demonstrate conformity to the new NOX and VOC MVEBs pursuant
to 40 CFR 93.104(e).

IV. Final Actions

    EPA is taking four separate but related actions regarding the
Knoxville Area's redesignation to attainment and maintenance of the
2008 8-hour ozone NAAQS. First, EPA is approving Tennessee's section
182(a)(1) base year emissions inventory for the 2008 8-hour ozone
standard for the Knoxville Area into the SIP. Approval of the base year
inventory is a prerequisite for EPA to redesignate the Area from
nonattainment to attainment.
    Second, EPA is determining that the Knoxville Area is attaining the
2008 8-hour ozone NAAQS based on complete, quality-assured and
certified monitoring data for the 2011-2013 monitoring period. The
2012-2014 data in the Air Quality System indicates that the Area is
continuing to attain the 2008 8-hour ozone NAAQS.
    Third, EPA is approving the maintenance plan for the Knoxville
Area, including the NOX and VOC MVEBs for 2011 and 2026,
into the Tennessee SIP (under CAA section 175A). The maintenance plan
demonstrates that the Area will continue to maintain the 2008 8-hour
ozone NAAQS, and the budgets meet all of the adequacy criteria
contained in 40 CFR 93.118(e)(4) and (5).
    Fourth, EPA is determining that Tennessee has met the criteria
under CAA section 107(d)(3)(E) for the Knoxville Area for redesignation
from nonattainment to attainment for the 2008 8-hour ozone NAAQS. On
this basis, EPA is approving Tennessee's redesignation request for the
2008 8-hour ozone NAAQS for the Knoxville Area. As mentioned above,
approval of the redesignation request changes the official designation
of Blount and Knox Counties and the portion of Anderson County in the
Knoxville Area for the 2008 8-hour ozone NAAQS from nonattainment to
attainment, as found at 40 CFR part 81.
    EPA is also finding the newly-established NOX and VOC
MVEBs for the Knoxville Area adequate for the purpose of transportation
conformity. Within 24 months from this final rule, the transportation
partners will need to demonstrate conformity to the new NOX
and VOC MVEBs pursuant to 40 CFR 93.104(e).

V. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of the maintenance plan under CAA section
107(d)(3)(E) are actions that affect the status of geographical area
and do not impose any additional regulatory requirements on sources
beyond those required by state law. A redesignation to attainment does
not in and of itself impose any new requirements, but rather results in
the application of requirements contained in the CAA for areas that
have been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, these actions merely approve state law as meeting Federal
requirements and do not impose additional requirements beyond those

imposed by state or federal law. For these reasons, these actions:
     Are not a significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     are not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 11, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control.

    Dated: July 6, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.
    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart RR--Tennessee

0
2. Section 52.2220(e) is amended by adding two new entries for ``2008
8-hour Ozone Maintenance Plan for the Knoxville Area'' and ``2008 8-
hour Ozone Emissions Inventory for the Knoxville Area'' at the end of
the table to read as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (e) * * *

                                EPA-Approved Tennessee Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                  Applicable
  Name of non-regulatory SIP     geographic or      State       EPA Approval
          provision              nonattainment    effective         date                  Explanation
                                     area            date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2008 8-hour Ozone Maintenance  Blount County,       11/14/14  7/13/15 [Insert  .................................
 Plan for the Knoxville Area.   Knox County,                   citation of
                                and a portion                  publication].
                                of Anderson
                                County.
2008 8-hour Ozone Emissions    Blount County,       11/14/14  ...............  .................................
 Inventory for the Knoxville    Knox County,
 Area.                          and a portion
                                of Anderson
                                County.
----------------------------------------------------------------------------------------------------------------

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
3. The authority citation for part 81 continues to read as follows:

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

0
4. In Sec.  81.343, the table entitled ``Tennessee-2008 8-Hour Ozone
NAAQS (Primary and secondary)'' is amended by revising the entries for
``Knoxville, TN,'' ``Anderson County (part),'' ``Blount County,'' and
``Knox County'' to read as follows:

Sec.  81.343  Tennessee.

* * * * *

                                        Tennessee-2008 8-Hour Ozone NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                            Designation                        Category/Classification
        Designated area        ---------------------------------------------------------------------------------
                                    Date \1\            Type               Date \1\                 Type
----------------------------------------------------------------------------------------------------------------
Knoxville, TN \2\.............  This action is    Attainment......  .....................  .....................
                                 effective 7/13/
                                 15.
Anderson County (part):
    2000 Census tracts: 202,    ................  ................  .....................  .....................
     213.02.
Blount County.................  ................  ................  .....................  .....................
Knox County...................  ................  ................  .....................  .....................

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ This date is July 20, 2012, unless otherwise noted.
\2\ Excludes Indian country located in each area, unless otherwise noted.
\3\ Includes any Indian country in each county or area, unless otherwise specified.

* * * * *
[FR Doc. 2015-17055 Filed 7-10-15; 8:45 am]
 BILLING CODE 6560-50-P