NOMINATION OF THE AEROSOL METERED-DOSE INHALER (MDI)

AS AN ESSENTIAL USE FOR 2009

Party/Country:			United States of America

Contact Person:		Hodayah Finman

Title:				United States Department of State

Address:			2201 C Street, NW

	Washington, DC 20520

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

Email<EMAIL_ADDRESS>
Expert

Organization:			United States Environmental Protection Agency

Contact Person: 		Kirsten M. Cappel

Address:			Office of Air and Radiation (MC: 6205J)

1200 Pennsylvania Avenue, NW

				 Washington, DC 20460

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

E-mail<EMAIL_ADDRESS>

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 (MDIs) 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.

Chlorofluorocarbons (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 United States is not requesting CFCs for 2009
for use in MDIs where the sole active ingredient is salbutamol.  The
United States established a phaseout date of December 31, 2008 for these
products, after which time it will be illegal to market them.

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

Cromolyn,

Epinephrine,

Ipratropium,

Nedocromil,

Pirbuterol,

Salbutamol (in combination), and

Triamcinolone.

C.	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
that the U.S. is not 	nominating CFCs for MDIs to meet export demand.

D. 	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	2009 Quantity (metric tonnes)

CFC-11, CFC-12, and CFC-114	282  metric tonnes

The United States is the intended market for the sale and/or
distribution of the MDIs.  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 COPDs, 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.

COPD 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: 2006" which contains statistics concerning the prevalence,
mortality, and treatment of asthma and COPD in the United States.  The
report states that:

“An estimated 29.8 million Americans have ever been diagnosed with
asthma by a health care professional (p. 13).

Asthma ranks among the top 10 most prevalent conditions causing
limitations of activity (p. 13).

Close to 20 million Americans currently have asthma, of which 11 million
had an asthma attack in 2003 (p. 13).

Asthma is the leading serious chronic illness of children in the U.S.
In 2003, an estimated 6.2 million children under age 18 (1.2 million
under the age of 5) had asthma, of which 4 million had an asthma attack
(p. 13).

[In children, asthma] is the number one cause of school absences
attributed to chronic conditions, leading to an estimated 12.8 million
school days lost annually (p. 13).

Asthma incurs an estimated annual economic cost of $16.1 billion to [the
U.S.].  This amount consists of $11.5 billion in direct healthcare costs
and $4.6 billion in indirect costs (e.g. lost productivity) (p. 16).

In 2002, over 4,000 people died of asthma in the United States (p. 15).

In addition to those with asthma, more than 10.7 million U.S. adults
(aged 18 and over) were estimated to have COPD in 2003 (p. 21).

COPD is the fourth-ranking cause of death, claiming the lives of 120,555
Americans in 2002 (p. 22).

According to estimates by the National Heart, Lung, and Blood Institute,
in 2004, the annual cost to the [U.S] for COPD was $37.2 billion.  This
included $20.9 billion in direct health care expenditures, $8.9 billion
in indirect morbidity costs and $7.4 billion indirect mortality costs
(p. 23).”

The problem is not limited to the United 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.
 For example, last year, for the first time since the inception of the
exemption program, the U.S. Government did not nominate CFC MDIs where
the sole active ingredient is salbutamol for an exemption for 2008.

The need for an essential use exemption remains while suitable
alternatives are developed for certain uses and to 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 2009 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 United States Food
and Drug Administration (U.S. FDA).  These regulations describe the
criteria that U.S. FDA 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 U.S.
FDA website at http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
by searching for rules published on July 24, 2002.  The U.S. FDA 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
solely salbutamol, reflecting substantial progress towards phaseout of
essential uses in the United States.  Please see Section 5 of this
document for more information on the U.S. FDA 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, U.S. FDA 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 U.S. FDA.  Also, the United States
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, U.S. FDA 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 whether
a product using ODSs is no longer medically essential.  The U.S. FDA
finalized its first action to remove the essentiality of a medical
device in April 2005 with the ban on the sale and distribution of CFC
salbutamol MDIs effective December 31, 2008.  In addition, at the 18th
Meeting of the Parties to the Montreal Protocol (MOP), in accordance
with Decision XVII/5, the United States announced the intention to
publish two proposed rules to determine non-essentiality of the vast
majority of CFCs for MDIs in May and June of 2007.  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 continued
reduction of CFCs nominated by the United States for essential uses.

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 U.S. FDA 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 U.S. FDA.  The final rule was published
in the Federal Register on 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 U.S. FDA would use for
determining whether the use of an ODS in a medical product is no longer
essential.  The final rule provided that to remove an essential use
designation, FDA must find that:

At least one non-ODS product with the same active moiety is marketed
with the same route of administration, for the same indication, and with
approximately the same level of convenience of use as the ODS product
containing that active moiety;

Supplies and production capacity for the non-ODS product(s) exist or
will exist at levels sufficient to meet patient need;

Adequate U.S. postmarketing use data is available for the non-ODS
product(s); and

Patients who medically required the ODS product are adequately served by
the non-ODS product(s) containing that active moiety and other available
products.

Furthermore, to remove the essential use designation of an active moiety
marketed in an ODS product represented by one NDA, there must be at
least one acceptable alternative, while for an active moiety marketed in
ODS products and represented by two or more NDAs, there must be at least
two acceptable alternatives (70 FR 17171).

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

 	phaseout date for the sale of CFC salbutomol products effective
December 31, 2008.  The United States has not traditionally exported CFC
salbutamol products to A5 countries.  However, as part of the U.S.
regulations on production for basic domestic needs, the U.S. does export
CFCs to Article 5 countries to meet their demand for manufacturing MDIs.

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 began rulemaking processes in 2006 to examine the
potential phaseout of CFC MDIs where the active ingredient is not solely
salbutamol.  U.S. FDA 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.  U.S. FDA has
already held two advisory council meetings, which are a preliminary step
for the agency to begin consideration of this issue.  At the 18th MOP,
in accordance with Decision XVII/5, the United States announced the
intention to publish two proposed rules to determine non-essentiality of
the vast majority of CFCs for MDIs in May and June of 2007.

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

The U.S. has made substantial progress 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, U.S. FDA 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 U.S. FDA. In 2002, U.S. FDA
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.
Over the last several years, the US has continued to allocate essential
use allowances for a reduced amount of CFCs for the manufacture of
essential use MDIs.

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. are undertaking 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 are taken in accordance
with relevant regulations of U.S. FDA.

The International Pharmaceutical Aerosol Consortium (IPAC), to which
many U.S. MDI manufacturers belong, has also undertaken education
efforts, some with the assistance of the U.S. Environmental Protection
Agency (U.S. EPA).  Government and industry education efforts include
the following:

World Wide Web Sites

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

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 – U.S. EPA, U.S. FDA, 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).  U.S. EPA and U.S. FDA 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 have 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.  A second
major pharmaceutical company, Schering-Plough, established the
“SP-Cares” program, which provides free SP drugs to qualified
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 U.S. FDA 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.  U.S. EPA expects these
activities to increase in the next year as patients continue to
transition to salbutamol HFA MDIs.

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 there are several MDIs with an alternative (non-CFC) propellant
available in the U.S., these products represent only a fraction of the
many drugs currently available in an MDI format.  U.S. FDA regulations
published in 2002 describe the criteria that FDA 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 patients and,
therefore, the FDA 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)

Dry Powder Inhalers (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, manufacturers include leaflets 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 United States carry a U.S.
notification that the contents of the MDI include CFCs.

To encourage doctor and patient acceptance and use of CFC-free MDIs, MDI
companies in the United States 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 U.S. FDA.

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 U.S. FDA 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 U.S. FDA 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.

U.S. 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 U.S. FDA]
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 U.S. FDA 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 U.S. FDA 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 US 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)

2,981.55

3,044.61

3,300.2

	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 U.S. FDA examines data on holdings of CFCs and recommends
adjustments to the amounts nominated and subsequently allocated through
U.S. EPA regulation 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 2006 accounting framework under separate cover.  EPA will
submit this information in February 2007.

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

The U.S. Accounting Framework will 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.

  PAGE  1

  if  =and(  section  1 = 8,   PAGE \* Arabic   1 =52)  0 = 1
"518830.02-D.C. Server 1A - MSW" ""


[Federal Register Volume 80, Number 98 (Thursday, May 21, 2015)]
[Notices]
[Pages 29359-29364]
[FR Doc No: 2015-12284]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74979; File No. SR-NASDAQ-2015-049]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change Relating to the Listing and
Trading of the Shares of the PowerShares DB Optimum Yield Diversified
Commodity Strategy Portfolio, PowerShares Agriculture Commodity
Strategy Portfolio, PowerShares Precious Metals Commodity Strategy
Portfolio, PowerShares Energy Commodity Strategy Portfolio, PowerShares
Base Metals Commodity Strategy Portfolio and PowerShares Bloomberg
Commodity Strategy Portfolio, Each a Series of PowerShares Actively
Managed Exchange-Traded Commodity Fund Trust

May 15, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934

(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 30, 2015, The NASDAQ Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in in Items I
and II below, which Items have been prepared by Nasdaq. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes a rule change with respect to PowerShares DB
Optimum Yield Diversified Commodity Strategy Portfolio, PowerShares
Agriculture Commodity Strategy Portfolio, PowerShares Precious Metals
Commodity Strategy Portfolio, PowerShares Energy Commodity Strategy
Portfolio, PowerShares Base Metals Commodity Strategy Portfolio and
PowerShares Bloomberg Commodity Strategy Portfolio (each, a ``Fund,''
and collectively, the ``Funds''), each a series of PowerShares Actively
Managed Exchange-Traded Commodity Fund Trust (the ``Trust'').
    The rule change is being filed to reflect a proposed change to the
current principal investment strategies of each Fund (which are set
forth in detail in an order previously granted by the Commission \3\)
to permit each Fund to invest in additional instruments and asset types
as part of their principal investment strategies, in addition to the
investments permitted by the Prior Order.
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    \3\ See Securities Exchange Act Release No. 73078 (Sept. 11,
2014), 79 FR 55851 (Sept. 17, 2014) (SR-NASDAQ-2014-80) (the ``Prior
Notice''); see also Securities Exchange Act Release No. 73471
(October 30, 2014), 79 FR 65751 (Nov. 5, 2014) (SR-NASDAQ-2014-080)
(the ``Prior Order,'' and, together with the Prior Notice, the
``Prior Release'').
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    Except for the changes discussed below, all other facts presented
and representations made in the Prior Release remain unchanged and in
full effect. All capitalized terms referenced but not defined herein
have the same meaning as in the Prior Release.
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at Nasdaq's principal office, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Each Fund is an actively managed exchange-traded fund (``ETF'')
whose shares (``Shares'') are offered, or will be offered, by the
Trust, a statutory trust organized under the laws of Delaware. The
Trust is registered with the Commission as an investment company and
has filed a registration statement on Form N-1A with the Commission.\4\
The Commission previously approved the listing and trading on the
Exchange of the Shares of each Fund \5\ under Nasdaq Rule 5735, which
governs the listing and trading of Managed Fund Shares \6\ on the
Exchange.\7\ Shares of PowerShares DB Optimum Yield Diversified
Commodity Strategy Portfolio have commenced listing and trading on the
Exchange; Shares of the other Funds have not.
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    \4\ A description of each Fund's investment strategy is set
forth in the Trust's registration statement on Form N-1A that the
Trust filed with the Commission (the ``Registration Statement'').
See Pre-effective Amendment No. 1 to the Registration Statement for
the Trust, dated May 20, 2014 (File Nos. 333-193135 and 811-22927)
(for each of PowerShares Agriculture Commodity Strategy Portfolio,
PowerShares Precious Metals Commodity Strategy Portfolio,
PowerShares Energy Commodity Strategy Portfolio and PowerShares Base
Metals Commodity Strategy Portfolio). The descriptions of the Funds
and the Shares contained herein are based, in part, on information
in the Registration Statement.
    \5\ See supra, note 4 [sic].
    \6\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a-1) (the ``1940 Act'') organized
as an open-end investment company or similar entity that invests in
a portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Index Fund Shares, listed
and traded on the Exchange under Nasdaq Rule 5705, seeks to provide
investment results that correspond generally to the price and yield
performance of a specific foreign or domestic stock index, fixed
income securities index or combination thereof.
    \7\ The Commission approved Nasdaq Rule 5735 in Securities
Exchange Act Release No. 57962 (June 13, 2008), 73 FR 35175 (June
20, 2008) (SR- NASDAQ-2008-039).
---------------------------------------------------------------------------

    In this proposed rule change, the Exchange proposes to permit the
listing or continued listing of the Shares if the Funds revise their
investment strategies to include additional instruments in their
portfolios to implement their investment objectives.\8\
---------------------------------------------------------------------------

    \8\ The changes described herein will be effective contingent
upon effectiveness of a post-effective amendment to the Registration
Statement of the Trust, on behalf of each Fund. The changes
described herein will not be implemented until such proposed rule
change is declared operative.
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Principal Investments
    As stated in the Prior Release, each Fund's investment objective is
to seek long-term capital appreciation. The Prior Release states that
each Fund seeks to achieve its investment objective by investing, under
normal circumstances,\9\ in a combination of: (i) A wholly-owned
subsidiary organized under the laws of the Cayman Islands (each, a
``Subsidiary,'' and collectively, the ``Subsidiaries''), (ii)
``exchange-traded products or exchange-traded commodity pools,'' \10\
and (iii) U.S. Treasury Securities, money market mutual funds, high
quality commercial paper and similar instruments (``Collateral
Instruments'').\11\
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    \9\ The term ``under normal circumstances'' includes, but is not
limited to, the absence of extreme volatility or trading halts in
the equity, commodities and futures markets or the financial markets
generally; operational issues causing dissemination of inaccurate
market information; or force majeure type events such as systems
failure, natural or manmade disaster, act of God, armed conflict,
act of terrorism, riot or labor disruption, or any similar
intervening circumstance.
    \10\ Specifically, the Prior Release noted that the Funds will
invest in: (1) ETFs that provide exposure to commodities as would be
listed under Nasdaq Rules 5705 and 5735; (2) exchange-traded notes
(``ETNs'') that provide exposure to commodities as would be listed
under Nasdaq Rule 5710; or (3) exchange-traded pooled investment
vehicles that invest primarily in commodities and commodity-linked
instruments as would be listed under Nasdaq Rules 5711(b), (d), (f),
(g), (h), (i), and (j) (``Commodity Pool'' or ``Commodity Pools'').
    \11\ For a Fund's purposes, money market instruments will
include: Short-term, high quality securities issued or guaranteed by
non-U.S. governments, agencies, and instrumentalities; non-
convertible corporate debt securities with remaining maturities of
not more than 397 days that satisfy ratings requirements under Rule
2a-7 of the 1940 Act; money market mutual funds; and deposits and
other obligations of U.S. and non-U.S. banks and financial
institutions.
---------------------------------------------------------------------------

    The Prior Release also states that each Subsidiary will invest in
exchange-traded futures contracts linked to commodities (``Commodities
Futures'') to provide its parent Fund with additional indirect exposure
to the commodities markets. Each Fund's investment in its Subsidiary is
designed to help the Fund obtain exposure to Commodities Futures
returns in a

manner consistent with the federal tax requirements applicable to
regulated investment companies, such as the Funds, which limit the
ability of investment companies to invest directly in derivative
instruments such as the Commodities Futures.
    In this proposed rule change, the Funds seek the ability for the
Funds and the Subsidiaries, as applicable, to also invest in a variety
of other securities and instruments beyond those set forth in the Prior
Release, as follows:
     Each Fund, which already may invest in ETFs, ETNs and
Commodity Pools, seeks to also invest in: (i) Other investment
companies,\12\ to the extent permitted under the 1940 Act,\13\ and (ii)
exchange-traded commodity-linked equity securities \14\ (collectively,
these are ``Commodity-Related Assets'').
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    \12\ In addition to ETFs, the other investment companies will
consist of non-exchange traded U.S. registered open-end investment
companies (mutual funds), closed-end investment companies traded on
U.S. exchanges, or exchange-traded non-U.S. investment companies
traded on foreign exchanges.
    \13\ Each Fund's investment in securities of other investment
companies may exceed the limits permitted under the 1940 Act, in
accordance with certain terms and conditions set forth in a
Commission exemptive order issued to an affiliate of the Trust
(which applies equally to the Trust) pursuant to Section 12(d)(1)(J)
of the 1940 Act. See Investment Company Act Release No. 30029 (Apr.
10, 2012) (File No. 812-13795) or, in the case of non-U.S.
investment companies, pursuant to SEC No-Action relief. See Red
Rocks Capital, LLC (pub. avail. June 3, 2011).
    \14\ Exchange-traded commodity-linked equity securities
(``Equity Securities'') will be comprised of exchange-traded common
stocks of companies that operate in commodities, natural resources
and energy businesses, and in associated businesses, as well as
companies that provide services or have exposure to such businesses.
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     Each Subsidiary, which already may invest in Commodities
Futures, now also seeks to invest in: (i) Exchange traded futures
contracts on commodity indices, (ii) commodity-linked notes,\15\ (iii)
ETNs, (iv) exchange-traded options on Commodities Futures
(``Options''),\16\ (v) centrally-cleared or over the counter (``OTC'')
swaps on commodities (``Swaps'') and (vi) commodity-related forward
contracts (``Forwards'') (collectively, these are ``Commodity-Linked
Instruments''), which provide exposure to the investment returns of the
commodities markets, without investing directly in physical
commodities.
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    \15\ Such commodity-linked notes generally will not be exchange-
traded; however it is possible that in the future some of those
instruments could be listed for trading on an exchange.
    \16\ The Prior Release noted that with respect to Commodities
Futures held indirectly through a Subsidiary, not more than 10% of
the weight of such Commodities Futures in the aggregate shall
consist of instruments whose principal trading market is not a
member of the Intermarket Surveillance Group (``ISG'') or a market
with which the Exchange does not have a comprehensive surveillance
sharing agreement. The Funds now clarify that Options and commodity
index futures will be subject to the same restrictions as
Commodities Futures, and that Options and commodity index futures
will be considered in the aggregate with Commodities Futures.
Therefore, with respect to Commodities Futures, commodity index
futures and Options, not more than 10% of the weight of such
Commodities Futures, commodity index futures, and Options, in the
aggregate, shall consist of instruments whose principal trading
market is not a member of the ISG or a market with which the
Exchange does not have a comprehensive surveillance sharing
agreement. This 10% limitation applicable to Commodities Futures,
commodity index futures, and Options, in the aggregate, is separate
from the 10% limitation applicable to exchange traded equity
securities described infra, and is determined separately from this
other limitation.
---------------------------------------------------------------------------

     In addition, each Fund may hold instruments that its
respective Subsidiary is entitled to hold, and vice versa, to the
extent consistent with federal tax requirements.
    The Prior Release noted that all of the exchange-traded securities
held by a Fund will be traded in a principal trading market that is a
member of ISG or a market with which the Exchange has a comprehensive
surveillance sharing agreement. The Funds propose to invest in Equity
Securities, closed-end funds, ETFs, ETNs, Commodity Pools and non-U.S.
investment companies that are not traded in a principal trading market
that is a member of ISG or a market with which the Exchange has a
comprehensive surveillance sharing agreement; however, not more than
10% of each Fund's investments in these investments (in the aggregate)
will be invested in instruments that trade in markets that are not
members of the ISG or that are not parties to a comprehensive
surveillance sharing agreement with the Exchange.
    These additional instruments are intended to support each Fund's
principal investment strategy by providing each Fund with the
flexibility to obtain additional exposure to the investment returns of
the commodities markets within the limits of applicable federal tax
requirements and without investing directly in physical commodities.
Each Fund, either directly or through its respective Subsidiary, will
only invest in those commodity-linked notes, OTC Swaps, Forwards, or
other over-the-counter instruments that are based on the price of
relevant Commodities Futures, as applicable, and tend to exhibit
trading prices or returns that correlate with any Commodities Futures
and that will further the investment objective of such Fund.\17\ The
Funds represent that the descriptions of the original asset types
included in the Prior Release remain unchanged, and that the Funds and
their Subsidiaries will adhere to all investment restrictions set forth
in the Prior Release as they apply to the original asset types. The
Funds also represent that the investments in these additional asset
types will be consistent with each Fund's investment objective.
---------------------------------------------------------------------------

    \17\ Each Fund will enter into swap agreements and other over-
the-counter transactions only with large, established and well
capitalized financial institutions that meet certain credit quality
standards and monitoring policies. Each Fund will use various
techniques to minimize credit risk, including early termination, or
reset and payment of such investments, the use of different
counterparties or limiting the net amount due from any individual
counterparty.
---------------------------------------------------------------------------

    In conjunction with this proposed change to add various instruments
to the Funds' principal investment strategies, the following
information supplements or updates, as applicable, the information
contained in the Prior Release. Except for these changes, all other
facts presented and representations made in the Prior Release remain
unchanged and in full effect.
Net Asset Value
    As stated in the Prior Release, the Funds' administrator will
calculate each Fund's net asset value (``NAV'') per Share as of the
close of regular trading (normally 4:00 p.m., Eastern time (``E.T.''))
on each day Nasdaq is open for business. NAV per Share is calculated by
taking the market price of a Fund's total assets, including interest or
dividends accrued but not yet collected, less all liabilities, and
dividing such amount by the total number of Shares outstanding. The
Prior Release describes how various securities and instruments held by
each Fund or its Subsidiary--including ETFs, ETNs and Commodities
Futures--will be valued to calculate each Fund's NAV.
    The Funds now represent that, in addition to the foregoing as set
forth in the Prior Release: (i) Equity Securities, ETNs, and futures on
commodity indices will be valued at the last sales price or the
official closing price on the exchange where such securities
principally trade; (ii) investment companies will be valued using such
company's end of the day NAV per share, unless the shares are exchange-
traded, in which case they will be valued at the last sales price or
official closing price on the exchanges on which they primarily trade;
(iii) Options generally will be valued at the closing price (and, if no
closing price is available, at the mean of the last bid/ask quotations)
generally from the exchange where such instruments principally

trade; and (iv) Swaps, commodity-linked notes and Forwards generally
will be valued based on quotations from a pricing vendor (such
quotations being derived from available market- and company-specific
data), all in accordance with valuation procedures adopted by the Board
of Trustees of the Trust.
    All other valuation procedures pertaining to the Funds, and as set
forth in the Prior Release, are unchanged.
Availability of Information
    The Prior Release states that, on each business day, before
commencement of trading in Shares in the Regular Market Session \18\ on
the Exchange, each Fund will disclose on its Web site the identities
and quantities of its portfolio of securities and other assets (the
``Disclosed Portfolio'' as defined in Nasdaq Rule 5735(c)(2)) held by
such Fund and its Subsidiary, which will form the basis for each Fund's
calculation of NAV at the end of the business day. The Prior Release
also stated that the Disclosed Portfolio will include, as applicable,
the names, quantity, percentage weighting, and other characteristics of
securities and other assets held by a Fund and its Subsidiary.
Additionally, the Prior Release includes information on where investors
may obtain quotation and last sale information for the various
securities and instruments held by a Fund, including that quotation and
last sale information for any underlying Commodities Futures is
available via the quote and trade service of such Commodities Futures'
primary exchanges.
---------------------------------------------------------------------------

    \18\ See Nasdaq Rule 4120(b)(4) (describing the three trading
sessions on the Exchange: (1) Pre-Market Session from 4 a.m. to 9:30
a.m. E.T.; (2) Regular Market Session from 9:30 a.m. to 4 p.m. or
4:15 p.m. E.T.; and (3) Post-Market Session from 4 p.m. or 4:15 p.m.
to 8 p.m. E.T.).
---------------------------------------------------------------------------

    In addition to the foregoing, the Funds will disclose on a daily
basis on the Funds' Web site the following information regarding each
portfolio holding, as applicable to the type of holding: Ticker symbol,
CUSIP number or other identifier, if any; a description of the holding
(including the type of holding), the identity of the security or other
asset or instrument underlying the holding, if any; for options, the
option strike price; for Swaps, a description of the type of Swap;
quantity held (as measured by, for example, par value, notional value
or number of shares, contracts or units); maturity date, if any; coupon
rate, if any; effective date, if any; market value of the holding; and
percentage weighting of the holding in the Fund's portfolio. The Web
site information will be publicly available at no charge.
    Intra-day price information on the exchange-traded assets held by
the Fund and the Subsidiary, including the Equity Securities, ETNs,
Options, exchange-traded investment companies (including closed-end
funds) and exchange-traded futures contracts on commodity indices will
be available via the quote and trade service of the respective
exchanges on which they principally trade. Additionally, price
information on Swaps, commodity-linked notes, Forwards and non-exchange
traded investment companies will be available from major broker-dealer
firms or through subscription services, such as Bloomberg, Markit and
Thomson Reuters, which can be accessed by entities that have entered
into an authorized participant agreement with the Trust and other
investors.
Surveillance
    First, as noted in the Prior Release, trading in the Shares will be
subject to the existing trading surveillances, administered by both
Nasdaq and also the Financial Industry Regulatory Authority
(``FINRA''), on behalf of the Exchange, which are designed to detect
violations of Exchange rules and applicable federal securities
laws.\19\ FINRA, on behalf of the Exchange, will communicate as needed
regarding trading in the Commodities Futures, ETFs, ETNs and Commodity
Pools held by a Fund or a Fund's Subsidiary, as applicable, with other
markets and other entities that are members of the ISG.\20\ FINRA and
the Exchange each may obtain trading information regarding trading in
the Commodities Futures, ETFs, ETNs and Commodity Pool held by such
Fund or its Subsidiary, as applicable, from such markets and other
entities (as long as, for the Exchange, such markets and other entities
are members of ISG or have in place a comprehensive surveillance
sharing agreement with the Exchange). FINRA and the Exchange will
similarly be able to obtain information regarding the spot market
prices of the commodities underlying any commodity-linked notes, OTC
Swaps, or forward contracts.
---------------------------------------------------------------------------

    \19\ FINRA surveils trading on the Exchange pursuant to a
regulatory services agreement. The Exchange is responsible for
FINRA's performance under this regulatory services agreement.
    \20\ For a list of the current members of ISG, see
www.isgportal.org. The Exchange notes that not all components of the
Disclosed Portfolio may trade on markets that are members of ISG or
with which the Exchange has in place a comprehensive surveillance
sharing agreement.
---------------------------------------------------------------------------

    In addition to the foregoing: (i) FINRA, on behalf of the Exchange,
will communicate as needed regarding trading information it can obtain
relating to exchange-traded or centrally-cleared equity securities and
assets held by a Fund or its Subsidiary, as applicable, which include
exchange-traded Commodity-Related Assets and exchange-traded or
centrally-cleared Commodity-Linked Instruments, with other markets and
other entities that are members of the ISG; (ii) FINRA may obtain
trading information regarding trading in exchange-traded equity
securities and other assets held by each Fund and each Subsidiary, as
applicable, from such markets and other entities; and (iii) the
Exchange may obtain information regarding trading in exchange-traded
equity securities and other assets held by each Fund and each
Subsidiary from such markets and other entities (as long as such
markets and other entities are members of ISG or have in place a
comprehensive surveillance sharing agreement with the Exchange). The
Exchange has a general policy prohibiting the distribution of material,
non-public information by its employees.
    Second, the Prior Release states that all of the exchange-traded
equity securities held by a Fund will be traded in a principal trading
market that is a member of the ISG or a market with which the Exchange
has a comprehensive surveillance sharing agreement, and that with
respect to Commodities Futures held indirectly through a Subsidiary,
not more than 10% of the weight of such Commodities Futures, in the
aggregate, shall consist of instruments whose principal trading market
is not a member of the ISG or a market with which the Exchange does not
have a comprehensive surveillance sharing agreement. The Funds now
clarify that Options and commodity index futures will be subject to the
same restrictions as Commodities Futures, and that Options and
commodity index futures will be considered in the aggregate with
Commodities Futures. Therefore, with respect to Commodities Futures,
commodity index futures and Options, not more than 10% of the weight
\21\ of such Commodities Futures, commodity index futures, and Options,
in the aggregate, shall consist of instruments whose principal trading
market is not a member of the ISG or a market with which the Exchange
does not have a comprehensive surveillance sharing agreement.
Additionally, not more than 10% of each Fund's investments in Equity
Securities, closed-end funds, ETFs, ETNs,

Commodity Pools and non-U.S. investment companies (in the aggregate)
will be invested in securities that trade in markets that are not
members of the ISG or that are not parties to a comprehensive
surveillance sharing agreement with the Exchange.
---------------------------------------------------------------------------

    \21\ To be calculated as the value of the contract divided by
the total absolute notional value of a Subsidiary's instruments.
---------------------------------------------------------------------------

    Beyond the changes described above, there are no changes to any
other information included in the Prior Release, and all other facts
presented and representations made in the Prior Release remain true and
in effect. The Trust confirms that each Fund will continue to comply
with all initial and continued listing requirements under Nasdaq Rule
5735.
2. Statutory Basis
    Nasdaq believes that the proposal is consistent with Section 6(b)
of the Act in general, and Section 6(b)(5) of the Act in particular, in
that it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and in general, to protect
investors and the public interest.
    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will continue to be listed and traded on the Exchange pursuant
to the initial and continued listing criteria in Nasdaq Rule 5735. The
Exchange represents that trading in the Shares will be subject to the
existing trading surveillances, administered by both Nasdaq and FINRA,
on behalf of the Exchange, which are designed to detect violations of
Exchange rules and applicable federal securities laws and are adequate
to properly monitor trading in the Shares in all trading sessions. In
addition, paragraph (g) of Nasdaq Rule 5735 further requires that
personnel who make decisions on the open-end fund's portfolio
composition must be subject to procedures designed to prevent the use
and dissemination of material, non-public information regarding the
open-end fund's portfolio. Each Fund's and its Subsidiary's investments
will be consistent with such Fund's investment objective.
    FINRA may obtain information via ISG from other exchanges that are
members of ISG. In addition, the Exchange may obtain information
regarding trading in the Shares, Equity Securities, Commodities
Futures, ETFs, ETNs, and Commodity Pools held by each Fund or its
Subsidiary, as applicable, from markets and other entities that are
members of ISG, which includes securities and futures exchanges, or
with which the Exchange has in place a comprehensive surveillance
sharing agreement. In addition, as noted in the Prior Release, the
Exchange may obtain information from TRACE, which is the FINRA-
developed vehicle that facilitates mandatory reporting of over-the-
counter secondary market transactions in eligible fixed income
securities. With respect to Commodities Futures held indirectly through
a Subsidiary, not more than 10% of the weight of such Commodities
Futures, in the aggregate, shall consist of instruments whose principal
trading market is not a member of ISG or a market with which the
Exchange does not have a comprehensive surveillance sharing agreement.
    Options and commodity index futures will be subject to the same
restrictions as Commodities Futures, and Options and commodity index
futures will be considered in the aggregate with Commodities Futures.
Therefore, with respect to Commodities Futures, commodity index futures
and Options, not more than 10% of the weight \22\ of such Commodities
Futures, commodity index futures, and Options, in the aggregate, shall
consist of instruments whose principal trading market is not a member
of the ISG or a market with which the Exchange does not have a
comprehensive surveillance sharing agreement. Additionally, not more
than 10% of each Fund's investments in Equity Securities, closed-end
funds, ETFs, ETNs, Commodity Pools and non-U.S. investment companies
(in the aggregate) will be invested in securities that trade in markets
that are not members of the ISG or that are not parties to a
comprehensive surveillance sharing agreement with the Exchange.
---------------------------------------------------------------------------

    \22\ To be calculated as the value of the contract divided by
the total absolute notional value of a Subsidiary's instruments.
---------------------------------------------------------------------------

    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Exchange will obtain a representation from the issuer of the
Shares that the NAV per Share will be calculated daily and that the NAV
and the Disclosed Portfolio will be made available to all market
participants at the same time. In addition, a large amount of
information will be publicly available regarding the Funds and the
Shares, thereby promoting market transparency. Moreover, as noted in
the Prior Release, the Intraday Indicative Value, available on the
NASDAQ OMX Information LLC proprietary index data service will be
widely disseminated by one or more major market data vendors at least
every 15 seconds during the Regular Market Session. On each business
day, before commencement of trading in Shares in the Regular Market
Session on the Exchange, each Fund will disclose on its Web site the
Disclosed Portfolio of the Fund and the Subsidiary that will form the
basis for such Fund's calculation of NAV at the end of the business
day. Information regarding market price and trading volume of the
Shares will be continually available on a real-time basis throughout
the day on brokers' computer screens and other electronic services, and
quotation and last sale information for the Shares will be available
via Nasdaq proprietary quote and trade services, as well as in
accordance with the Unlisted Trading Privileges and the Consolidated
Tape Association plans for the Shares. Intra-day price information on
the exchange-traded assets held by a Fund and its Subsidiary, including
the Equity Securities, ETFs, exchange traded investment companies
(including closed-end funds) and exchange-traded futures contracts on
commodity indexes will be available via the quote and trade service of
the respective exchanges on which they primarily trade, as well as in
accordance with the Unlisted Trading Privileges and the Consolidated
Tape Association plans. Quotation and last sale information for any
underlying Commodities will be available via the quote and trade
service of their respective primary exchanges. Intra-day price
information on the exchange-traded assets held by the Fund and the
Subsidiary, including the Equity Securities, ETNs, Options, exchange-
traded investment companies (including closed-end funds) and exchange-
traded futures contracts on commodity indices will be available via the
quote and trade service of the respective exchanges on which they
principally trade. Additionally, price information on Swaps, commodity-
linked notes, Forwards and non-exchange traded investment companies
will be available from major broker-dealer firms or through
subscription services, such as Bloomberg, Markit and Thomson Reuters,
which can be accessed by entities that have signed authorized
participant agreements with a Fund and other investors.
    As noted above and in the Prior Release, the Funds' Web site will
include a form of the prospectus for each Fund and additional data
relating to NAV and other applicable

quantitative information. Moreover, prior to the commencement of
trading, the Exchange will inform its members in an Information
Circular of the special characteristics and risks associated with
trading the Shares. Trading in Shares of a Fund will be halted under
the conditions specified in Nasdaq Rules 4120 and 4121 or because of
market conditions or for reasons that, in the view of the Exchange,
make trading in the Shares inadvisable, and trading in the Shares will
be subject to Nasdaq Rule 5735(d)(2)(D), which sets forth circumstances
under which Shares of a Fund may be halted. In addition, as noted
above, investors will have ready access to information regarding each
Fund's holdings, the Intraday Indicative Value, the Disclosed
Portfolio, and quotation and last sale information for the Shares.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the continued listing and
trading of additional types of actively-managed exchange-traded
products that will enhance competition among market participants, to
the benefit of investors and the marketplace.
    For the above reasons, Nasdaq believes the proposed rule change is
consistent with the requirements of Section 6(b)(5) of the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The instruments and asset
types proposed to be added by this rule change, in connection with
those approved in the Prior Order, are consistent with the instruments
and asset types utilized by other actively managed funds in the
marketplace. The investment strategies utilized by the Funds, however,
remain different from other issues of Managed Fund Shares traded on the
Exchange, and therefore provide investors with another choice of
Managed Fund Shares. Moreover, the Exchange believes that the proposed
changes will enhance competition among existing issues of Managed Fund
Shares and will facilitate the trading of additional types of actively-
managed exchange-traded funds, all to the benefit of investors and the
marketplace.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
(a) By order approve or disapprove such proposed rule change; or (b)
institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2015-049 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street NE., Washington, DC 20549.

All submissions should refer to File Number SR-NASDAQ-2015-049. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site http://www.sec.gov/rules/sro.shtml.
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of Nasdaq. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2015-049 and should be submitted
on or before June 11, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-12284 Filed 5-20-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32087-32088]
[FR Doc No: 2013-12315]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30901; Amdt. No. 3536]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective May 29, 2013. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of May 29, 2013.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169; or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on May 10, 2013.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [Amended]

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

 EFFECTIVE UPON PUBLICATION

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC Date            State               City               Airport          FDC No.      FDC Date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
6/27/13..............  AK.............  Shishmaref.........  Shishmaref.........       3/4997      4/26/13  NDB Rwy 23, Amdt 1.
6/27/13..............  AK.............  Shishmaref.........  Shishmaref.........       3/4998      4/26/13  NDB Rwy 5, Amdt 1.
6/27/13..............  MT.............  Helena.............  Helena Rgnl........       3/5234      4/26/13  NDB D, Amdt 3.
6/27/13..............  MT.............  Baker..............  Baker Muni.........       3/5271      4/26/13  NDB Rwy 13, Orig-A.
6/27/13..............  MT.............  Baker..............  Baker Muni.........       3/5272      4/26/13  NDB Rwy 31, Orig-A.
6/27/13..............  AK.............  Minchumina.........  Minchumina.........       3/5426      4/26/13  NDB Rwy 3, Amdt 3.
6/27/13..............  AK.............  Aniak..............  Aniak..............       3/5822      4/26/13  ILS/DME Rwy 10, Amdt 7C.
6/27/13..............  AK.............  Aniak..............  Aniak..............       3/5823      4/26/13  LOC/DME Rwy 10, Amdt 3C.
6/27/13..............  AK.............  Aniak..............  Aniak..............       3/5824      4/26/13  NDB/DME Rwy 28, Amdt 3.
6/27/13..............  AR.............  Little Rock........  Bill and Hillary          3/6324      4/26/13  ILS OR LOC Rwy 22R, ILS Rwy 22R (CAT II),
                                                              Clinton National/                              ILS Rwy 22R (CAT III), Amdt 2B.
                                                              Adams Field.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-12315 Filed 5-28-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Notices]
[Page 54526]
[FR Doc No: 2011-22458]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fourth Meeting RTCA NextGen Advisory Committee (NAC)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: RTCA NextGen Advisory Committee (NAC).

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA NextGen Advisory Committee (NAC).

DATES: The meeting will be held September 29, 2011 from 9 a.m. to 4
p.m.

ADDRESSES: The meeting will be held at RTCA Headquarters, Colson/NBAA
Conference Room, 1150 18th Street, NW., Suite 910, Washington, DC
20036.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1150 18th Street,
NW., Suite 910, Washington, DC 20036; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for the NextGen Advisory Committee meeting. The agenda
will include:
     9 a.m. (Opening Plenary (Welcome and Introductions),
Chairman Dave Barger, President and CEO, JetBlue Airways.
     Official Statement of Designated Federal Official, Michael
Huerta, FAA Deputy Administrator.
     Review and Approval of May 19, 2011 Meeting Summary/Terms
of Reference.
     Chairman's Report--Chairman Barger.
     FAA Report--Michael Huerta.
     Subcommittee Report: NAC Subcommittee and Work Groups.
     Subcommittee Co-Chair, Steve Brown, Senior Vice President,
Operations and Administration, National Business Aviation Association
and Tom Hendricks, Senior Vice President, Safety, Security and
Operations, Air Transportation Association.
     Status Report--Data Comm Tasking.
     Break.
     Review and Approve Recommendations for Submission to FAA.
     AdHoc--Economic Incentives to Equip for NextGen.
     Review and Approve Recommendations for Submission to FAA.
     Business Case Gap Assessment for NextGen Equipage and
Operational Incentives.
     Review and Approve Recommendation for Submission to FAA.
     Enhancing Operations in Specific Regional Airspace.
     Lunch Break.
     Review and Approve Recommendations for Submission to FAA.
     NextGen Implementation Performance Measurement Criteria.
     Review and Approve Recommendation for Submission to FAA.
     Trajectory Operations Concept of Use for Mid-Term (2018).
     Afternoon Break.
     Review and Approve Recommendation for Submission to FAA.
     Metroplex Prioritization Criteria and Capabilities Applied
to the Metroplex Areas.
     Committee Discussion of 2012 Taskings--``What Comes
Next?''
     Other Business/Anticipated Issues for NAC Consideration
and Action at January/February 2012 meeting.
     Adjourn.

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FUTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on August 26, 2011.
Robert L. Bostiga,
RTCA Advisory Committee.
[FR Doc. 2011-22458 Filed 8-31-11; 8:45 am]
BILLING CODE 4910-13-P