[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Page 11815]
[FR Doc No: 2016-04927]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Orthopaedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on Wednesday, April 20,
2016, from 8 a.m. to 6 p.m.
    Location: Hilton Washington, DC/North, Salons A, B, C, and D, 620
Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301-
977-8900.
    Contact Person: S.J. Anderson, Center for Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, rm. 1643, 10903 New
Hampshire Ave., Silver Spring, MD 20993, email:
<EMAIL_ADDRESS>301 796-7047, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The Committee will discuss, make recommendations, and vote
on the premarket approval application for the Cartiva Synthetic
Cartilage Implant (SCI), sponsored by Cartiva, Inc. The Cartiva
Synthetic Cartilage Implant (SCI) is an organic polymer-based
biomaterial to mimic biologic cartilage. The device is to be indicated
for treatment of degenerative and post-traumatic arthritis in the first
metatarsophalangeal joint in the presence of good bone stock along with
the following clinical conditions: hallux valgus or hallux limitus,
hallux rigidus, and an unstable or painful metatarsophalangeal joint.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 13, 2016. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before April 5, 2016. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by April 6, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at<PHONE_NUMBER> at least 7 days in advance of
the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 29, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-04927 Filed 3-4-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 115 (Thursday, June 15, 2023)]
[Rules and Regulations]
[Pages 39170-39172]
[FR Doc No: 2023-12750]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0465]
RIN 1625-AA00

Safety Zone; Upper Mississippi River, Prairie du Chien, WI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters on the Upper Mississippi River between 636-635, east
of Island number one hundred seventy-two. The safety zone is needed to
protect personnel, vessels, and the marine environment from potential
hazards created by high-speed power vessels. Entry of vessels or
persons into this zone is prohibited unless specifically authorized by
the Captain of the Port, Sector Upper Mississippi River.

DATES: This rule is effective from 7:30 a.m. on June 23, 2023, through
6:30 p.m. on June 25, 2023. The rule is subject to enforcement from
7:30 a.m. through 6:30 p.m. each day it is effective.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0465 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MSTC Nathaniel Dibley, Sector Upper Mississippi River
Waterways Management Division, U.S. Coast Guard; telephone 314-269-
2550, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing an NPRM would be
impractical due to the date the event is taking place. It is
impracticable to publish an NPRM because we must establish this safety
zone by June 23, 2023, and lacks sufficient time to provide a
reasonable comment period and to consider those comments before issuing
the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
due to the date the event is taking place. Delaying the effective date
of this rule would be impracticable and contrary to public interest
because we must establish the safety zone by June 23, 2023, in order to
protect personnel, vessels, and the marine environment from the
potential safety hazards associated with the high speed power vessel
racecourse event occurring on that date.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The

Captain of the Port Sector Upper Mississippi River (COTP) has
determined that potential hazards associated with Great Lakes
Watercross Race, on June 23, 2023, will be a safety concern for anyone
within the marked area of the racecourse. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone while the race is being conducted.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7:30 a.m. through 6:30
p.m. each day on June 23 to June 25, 2023. The safety zone will cover
all navigable waters within the Great Lakes Watercross Race, on the
Upper Mississippi River, between Mile Markers 635 to 636 east of Island
number one hundred seventy-two. The duration of the zone is intended to
protect personnel, vessels, and the marine environment in these
navigable waters while the race is conducted. No vessel or person will
be permitted to transit the safety zone without obtaining permission
from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866, as amended by
Executive Order 14094 (Modernizing Regulatory Review). Accordingly,
this rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the limited
duration and narrowly tailored geographic areas of the safety zone.
Although this rule restricts access to the waters encompassed by the
safety zone, the effect of this rule will not be significant because
the local waterways users will be notified to ensure the safety zone
will result in minimal impact. In addition, normal marine traffic will
be minimally impacted as race official will be to pass traffic between
races. The navigation channel west of Island number one hundred
seventy-two will not be impacted by the safety zone and will remain
open. The vessels desiring to transit through or around the temporary
safety zone may do so upon express permission from the COTP or the
COTP's designated representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting from 7:30 a.m. to 6:30 p.m. that will prohibit
entry between Mile Markers 635-636 east of Island number one hundred
seventy-two. It is categorically excluded from further review under
paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1. A Record of Environmental Consideration supporting
this determination is available in the docket. For instructions

on locating the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping requirements, Security Measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0439 to read as follows:

Sec.  165.T08-0465  Safety Zone; Upper Mississippi River, Mile Markers
635-636 east of Island number one hundred seventy-two, Prairie du
Chien, WI.

    (a) Location. The following area is a safety zone: all navigable
waters within the Upper Mississippi River, Mile Markers 635-636 east of
Island number one hundred seventy-two, Prairie du Chien, WI.
    (b) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG)
assigned to units under the operational control o the USCG Sector Upper
Mississippi River.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative via VHF-FM channel 16, or through USCG Sector Upper
Mississippi River at<PHONE_NUMBER>. Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (c) Enforcement period: This safety zone will be subject to
enforcement from 7:30 a.m. through 6:30 p.m. each day from June 23 to
June 25, 2023.

    Dated: June 9, 2023.
A.R. Bender,
Captain, U.S. Coast Guard, Captain of the Port Sector Upper Mississippi
River.
[FR Doc. 2023-12750 Filed 6-14-23; 8:45 am]
BILLING CODE 9110-04-P


1 NOMINATION OF THE AEROSOL METERED DOSE INHALER ( MDI)

AS AN ESSENTIAL USE FOR 2008 Country: United States Contact Person: John Thompson Title: Division Director Address: U. S. Department of State Washington, DC 20520 Telephone: 202/ 647 9799 Fax: 202/ 647 5947 Email: ThompsonJE2@ state. gov Expert Contact Person*: Hodayah Finman Title: Team Leader Address: U. S. Environmental Protection Agency Office of Air and Radiation ( 6205J) 1200 Pennsylvania Avenue, NW Washington, DC 20460 Telephone: 202/ 343 9246 Fax: 202/ 343 2338 Email: finman. hodayah@ epa. gov * Expert( s) in the country who can be contacted for clarification. 2 I. Summary of Nomination A. Please identify and describe in detail the proposed uses. Please indicate for what disease or treatment the proposed use is intended. ( Decision IV/ 25, pars. 2 and 3)

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

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

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

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

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

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

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, the U. S. is not nominating CFCs for MDIs to meet export demand. 3 D. Please indicate below the quantity of CFCs1 requested for the proposed use in each year being nominated for each active ingredient and for each intended market for sale or distribution; if necessary, the quantities for intended markets may be best estimates from requesting companies. If more specific data are not available, data aggregated by region and product group may be submitted for Article 5( 1) intended markets for sale or distribution. ( Decision IV/ 25, pars. 2 and 3 and Decision XV/ 5, par. 2)

Nominated quantities of CFCs ( metric tonnes) for essential uses Ozone Depleting Substance 2008 Quantity ( metric tonnes)

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

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

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

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

This nomination requests CFCs solely for use in MDIs for the treatment of asthma and/ or COPD. Asthma and chronic obstructive pulmonary diseases ( COPD), such as emphysema and chronic bronchitis, reduce the capacity for breathing. In asthma and often in COPD, airways become inflamed and hyperreactive 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.

1 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. 4 Asthma and COPD greatly diminish the quality of life for patients and their families, and in severe cases may cause death.

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

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

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

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

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

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

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

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

  Asthma attacks bring an estimated 1.9 million Americans to emergency rooms each year and account for one in six of all pediatric emergency room visits in the U. S. ( p. 5) 5   Asthma cost the U. S. an estimated $ 11.3 billion in 1998. This amount includes direct health care expenses ($ 7.5 billion) and indirect costs such as lost productivity ($ 3.8 billion). ( p. 5)

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

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

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

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

The problem is not limited to the Unites States.

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

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

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

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

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

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

2. Does this use include any MDI product approved after 31 December 2000 for the treatment of asthma and/ or chronic obstructive pulmonary disease? ( Decision II/ 2, par. 2)

No. 6 B. Description of Transition Status The following elements should be addressed or updated in each year's nomination:

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

Consistent with the request of the Parties in Decision VIII/ 12, the United States has submitted to the UNEP Ozone Secretariat its transition strategy in the form of regulations developed by the U. S. Food and Drug Administration ( USFDA). These regulations describe the criteria that USFDA will use to determine when it is appropriate to remove the essential use designation from products that use ozone depleting substances. The final regulations were published in the Federal Register on July 24, 2002.2 The rule may be accessed on the USFDA website at http:// www. accessdata. fda. gov/ scripts/ oc/ ohrms/ index. cfm by searching for rules published on July 24, 2002. The USFDA issued a final rule on April 4, 2005 ( 70 FR 17169) that sets the date to remove the essential use designation for CFC MDIs whose active ingredient is salbutamol, reflecting substantial progress towards phaseout of essential uses in the U. S. Please see Section 5 of this document for more information on the USFDA rulemaking process.

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

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

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

2 " Use of Ozone Depleting Substances; Essential Use Determinations." 67 Federal Register 48370. 7 Significant progress has been made in recent years to facilitate an orderly transition to safe and effective CFC free alternatives. Following substantial investment in research and development by U. S. firms, and completion of the required safety tests for new drug products, USFDA has approved several new treatments for asthma and COPD that do not rely on CFCs ( see the table below). Additional alternatives are under review by USFDA. Also, the U. S. Government has overseen the consistent application of Decisions by the Parties regarding the allocation of essential use allowances by ensuring that the amount granted by the Parties is not allocated if it is not needed nationally. In 2002 USFDA issued the final regulations that provide the framework for the transition to CFC free alternatives in the United States. These regulations describe the criteria for determining if a product using ODSs is no longer medically essential. The USFDA finalized their first action to remove the essentiality of a medical device in 2004 with the ban on the sale and distribution of CFC salbutamol MDIs effective December 31, 2008. The accelerating shift by U. S. firms to CFC free products, as well as the success of these products in the U. S. market, is reflected in the more than 50% reduction in the 2008 U. S. nomination as compared to the total approved by the Parties for the U. S. for consumption in 2007 ( the 2008 amount is approximately one third of the U. S. 2007 nomination).

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

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

  The time required to seek USFDA approval of new therapies;

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

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

All CFC MDI's where the sole active ingredient is not salbutamol currently marketed in the United States do not have acceptable alternatives with the same active moieties. The standard to remove an essential use designation for products where there are not adequate alternatives available with the same active moiety provide that FDA must find that:   Substantial technical barriers do not exist to formulating the product without ODS;   The product does not provide an unavailable important public health benefits; and 8   Use of the product releases cumulatively significant amounts of ODS into the atmosphere or the release is warranted in view of the unavailable important public health benefits.

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

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

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

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

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

6. Explain what substitutes and alternatives to the proposed use are currently available in the domestic market and, to the extent known, in each intended 9 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). 10 7. Explain steps being taken to implement these substitutes and alternatives in the domestic market. ( Decision IV/ 25, pars. 1( a)( ii), 1( b)( i), 2 and 3( d))

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

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

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

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

  World Wide Web Sites USEPA and USFDA have websites with information on the transition to CFC free metered dose inhalers. They are located at www. fda. gov/ cder/ mdi/ and 11 http:// www. epa. gov/ ozone/ title6/ phaseout/ mdi/ index. html.

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

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

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

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

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

International professional associations such as the American Thoracic Society 12 ( ATS), the American Academy of Allergy, Asthma, and Immunology ( AAAAI), and the European Respiratory Society ( ERS) support medical professionals active in the treatment of asthma and COPD. These associations publish medical journals, reports and newsletters and organize medical congresses. These activities are designed to inform medical professionals about the management of asthma and COPD, and the range of treatment options available for their patients.

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

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

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

Although seven MDIs with an alternative ( non CFC) propellant are available in the U. S., these products represent only a fraction of the many drugs currently 13 available in an MDI format. USFDA regulations published in 2002 describe the criteria that the Agency uses to determine when it is appropriate to remove the essential use designation from products that use ozone depleting substances. One element of these criteria is the availability of at least two alternatives for a given use. In some instances, such as the essential use designation for salbutamol MDIs, there are at least two alternatives available to patient and, therefore, the USFDA established a date for a ban on the sale of CFC salbutamol MDIs. While other CFC free MDIs may be introduced in the next few years, it is clear that CFC MDIs will still be vital for the treatment of asthma and COPD in the U. S. for the near future.

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

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

  Most nebulizers " require a source of electricity or compressed gas, and are very bulky and complicated to set up and use."   Currently available hand held nebulizers are " inefficient."   Dose reproducibility in nebulizers " is not reliable."   Electric nebulizers require " 10 20 minutes to deliver a dose."

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

  Oral medication usually produces " more side effects than inhaled medication."   Some drugs which are effective by inhalation " are not absorbed as oral therapy."   Treatment guidelines " have favoured a move from oral to inhaled route for the treatment of respiratory diseases."

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

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

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

  DPIs are " difficult for patients with low inspiratory flow rates, " e. g. small children, COPD patients, and asthmatics suffering from an acute asthma attack.   DPIs require " special packaging for use in humid climates."   Patient acceptance of DPIs " is not uniform." 14 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 CFCfree MDIs from the packaging of CFC MDIs through the use of shapes, sizes, colors, trademarks, logos, and other design features. In addition, leaflets have been and will be included in the packages containing CFC free MDIs which inform patients of the differences between the CFC free MDI and the CFC MDI. These steps have been and will continue to be taken in accordance with relevant regulations of the U. S. FDA ( for example, 21 Code of Federal Regulations ( CFR) Part 201 ( dealing with labeling requirements for drugs) and Part 314 ( dealing with approval of new drugs). Also, all CFC MDIs sold in the U. S. carry a USEPA notification that the contents of the MDI includes CFCs.

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

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

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

Describe what steps have been taken to ensure that companies applying for MDI essential use exemptions participate in regulatory proceedings with a view toward legitimate environmental, health and safety concerns. 15 FDA regulations governing participation in regulatory proceedings generally prohibit any company, including any MDI company, from advancing environmental, health and safety concerns that are illegitimate, or from otherwise engaging in conduct that misleads or obfuscates. These regulations require, among other things, that:

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

  Any company filing a " citizen petition" with the USFDA must certify that the petition " includes representative data and information known to the petitioner which are unfavorable to the petition" [ 21 CFR § 10.30( b)]; and   Knowingly and willingly making a materially false statement or representation at a hearing that is part of a USFDA rulemaking process is a felony under U. S. criminal law [ 18 U. S. C. 1001( a)].

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

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

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

The waste minimization strategies employed in the manufacture of MDIs include:

  Use of a vapor return hose Vapor return hoses minimize emissions during the transfer of 16 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 17 leaks during the blending process.

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

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

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

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

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

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

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

CFCs Used for MDIs Prior to Nomination ( metric tonnes)

Ozone Depleting Substance 1993 1994 1995 CFC l1, 12, 113, 114 ( aggregate) 2981.55 3044.61 3300.2 18 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 nonessential by an importing Party.

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

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

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

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

5. Confirm that the nominating Party has given due consideration to the following. That: 19 a. Each company's existing stock of pharmaceutical grade CFCs ( including CFCs the company possesses or has title to, preand 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 preand 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. 20 IV. Reporting Accounting Framework for Essential Uses Other than Laboratory and Analytical Applications Accounting framework to be forwarded to the Ozone Secretariat under separate cover after January 31, 2006.