(Response) As stated above, we carefully evaluated the comments
submitted in response to the proposed rule and have determined that an
effective date of December 31, 2013, is appropriate for the removal of
the essential-use designation for Combivent Inhalation Aerosol and
Maxair Autohaler. We acknowledge that the presence of a non-CFC
replacement for Combivent Inhalation Aerosol and Maxair Autohaler may
be convenient for users. However, we note that a December 31, 2013,
effective date allows a reasonable time to permit the development of a
non-CFC replacement. Currently, we believe there are adequate non-CFC
alternatives for Combivent Inhalation Aerosol available in the form of
separate albuterol HFA MDIs and ipratropium bromide HFA MDIs. With
respect to Maxair Autohaler, we believe adequate non-CFC alternatives
exist in the form of Albuterol in HFA MDIs or in a nebulizer.
    The effective date we are establishing for the removal of the
essential-use designations for Combivent Inhalation Aerosol and Maxair
Autohaler provides over 3 additional years for manufacturers to scale
up production of albuterol HFA MDIs and ipratropium bromide HFA MDIs
and will help ensure that there will be adequate supplies of the MDIs
for patients. The effective date also provides over 3 years for
patients and their health care providers to consider the different
formulations of albuterol HFA MDI and levalbuterol HFA MDI and select
the most appropriate therapeutic alternative. We are also permitting
additional time for patients to transition from using a combination
product to using two separate MDIs, to choose and adapt to a
traditional press-and-breathe MDI, or to switch to using a nebulized
solution.
    We believe that educating patients and health care providers about
the transition to other asthma treatments is very important to an
orderly and safe transition of patients currently using Combivent
Inhalation Aerosol and Maxair Autohaler, particularly for elderly
patients, those with co-morbid conditions who are taking multiple
medications, or those patients with coordination problems. The need to
ensure that we have permitted sufficient time for patient education for
transitioning from a Combivent Inhalation Aerosol or a Maxair Autohaler
to an appropriate non-CFC substitute was an important factor in our
decision to extend the proposed effective date in this final rule, to
December 31, 2013. We will actively monitor the transition to CFC-free
alternatives. Anyone who wishes to discuss a cooperative educational
effort with DHHS and FDA should contact FDA or the Office of the
Secretary of DHHS.
    With respect to a conditional effective date for Combivent
Inhalation Aerosol, we believe it is important to specify a date
certain when Combivent Inhalation Aerosol can no longer be marketed so
patients and their health care providers may transition to therapeutic
alternatives in a timely and orderly manner. We also note that the
December 31, 2013, effective date allows a reasonable time to permit
the development and approval of a non-CFC replacement for Combivent
Inhalation Aerosol.
    We decline to exclude Combivent Inhalation Aerosol from the
rulemaking, as requested by BI. As discussed elsewhere in this
document, the United States is committed to phasing out the remaining
essential-use designations in the context of the Montreal Protocol. We
believe finalizing this rule now and setting an effective date for
Combivent Inhalation Aerosol that provides over a 3-year transition
affects the eventual transition in a manner that is consistent with our
duty to protect the public health.

F. Conclusions

    We conclude there are no substantial technical barriers to
formulating flunisolide, triamcinolone, metaproterenol, pirbuterol,
albuterol and ipratropium in combination, cromolyn, and nedocromil as
products that do not release ODSs. The evidence presented to the agency
during this rulemaking does not meet the high threshold required by the
first criterion on substantial technical barriers. We therefore
conclude that oral pressurized MDIs containing flunisolide,
triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in
combination, cromolyn, and nedocromil are no longer essential uses of
ODSs and will be removed from the list of essential uses in Sec.
2.125(e) as of the effective dates specified in this rule.

V. Environmental Impact

    The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Division
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday. Under FDA's regulations implementing the National
Environmental Policy Act (21 CFR part 25), an action of this type would
require an environmental assessment under 21 CFR 25.31(a).

VI. Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is an economically significant regulatory action under
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because only one CFC MDI manufacturer may possibly
be considered a small entity, and one single small entity among an
industry of hundreds does not constitute a ``substantial number'' under
the Regulatory Flexibility Act, the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. This final rule may
result in a 1-year expenditure that would meet or exceed this amount.
    The Congressional Review Act requires that regulations that have
been identified as being major must be submitted to Congress before
taking effect. This rule is major under the Congressional Review Act.
    Limitations in the available data prevent us from estimating
quantitatively the anticipated costs and benefits to society, so we
focus instead on proxy measures. The costs of this final rule include
the benefits lost by consumers who would have bought MDIs at current
prices, but would not buy them at higher prices. Consumers of
flunisolide MDIs (Aerobid Inhaler System) and MDIs delivering albuterol
and ipratropium in combination (Combivent Inhalation Aerosol) will face
higher prices because available substitutes cost more. In contrast,
users of triamcinolone MDIs (Azmacort Inhalation Aerosol),
metaproterenol MDIs (Alupent Inhalation Aerosol), pirbuterol MDIs
(Maxair Autohaler), cromolyn sodium MDIs (Intal Inhaler), and
nedocromil sodium MDIs (Tilade Inhaler) will be able to switch to less
expensive alternatives. Consumers of these products may benefit as they
are made aware of less expensive, therapeutically adequate alternatives
to the MDIs they currently use. In the transition, these consumers may
also be inconvenienced by the need to become accustomed to using an
alternative product.
    Net spending by consumers and third-party payers, including Federal
and State Governments, will increase as patients switch to more
expensive therapeutic alternatives; the potential for spending
reductions by users of Azmacort, Alupent, Maxair, Intal, and Tilade is
not enough to offset expected increases in spending by users of Aerobid
and Combivent. These spending increases, however, overstate social
costs because, to some extent, they represent resources transferred
from drug buyers (consumers and third-party payers) to drug sellers
(drug manufacturers, wholesalers, pharmacies). We estimate that the
introduction of generic albuterol HFA MDIs to the market will eliminate
price and spending increases resulting from this final rule. The
benefits of this rule include the value of improvements in the
environment and public health that may result from reduced emissions of
ODSs (for example, the reduced future incidence of skin cancers and
cataracts). The benefits also include improved expected returns on
investments in environmentally-friendly technologies and greater
international cooperation to comply with the Montreal Protocol.
    Estimated spending increases (summarized in tables 1 and 2 of this
document) cannot be attributed solely to this rule. These increases
result from Combivent users switching to Atrovent Inhalation Aerosol
and albuterol HFA MDIs. The increased spending from this switch, in
turn, is driven by the switch from inexpensive generic albuterol CFC
MDIs to more expensive albuterol HFA MDIs, which was mandated in an
earlier rulemaking (70 FR 17168, April 4, 2005). The spending increases
described here may therefore be viewed as costs of the larger
transition away from CFC products, rather than costs resulting from
this rule in particular. We cannot conclusively attribute these
estimated spending increases to either the prior rule or this final
rule. While table 1 provides the annual quantifiable effects after all
moieties have been removed from the market, table 2 provides the total
impacts, factoring in the staggered phase-out and using two different
possibilities for the date of HFA patent expiration.

Table 1.--Summary of Annual Quantifiable Effects of the Final Rule After All Seven Moieties Are Removed From the
                                                     Market
----------------------------------------------------------------------------------------------------------------
    Patient Days of      Increased MDI Expenditures,   Possible Reduction in Days    Reduced CFC Emissions From
   Therapy Affected            in 2009 dollars         of Therapy Used (millions)        Phase-Out (tonnes)
----------------------------------------------------------------------------------------------------------------
300 million                         $90-$280 million                      0.20-4.2                       310-365
----------------------------------------------------------------------------------------------------------------

                  Table 2.--Summary of Impacts From Phase-Out to Date of HFA Patent Expiration
----------------------------------------------------------------------------------------------------------------
                          Possible Change in Use of                                 Increases in Expenditures on
  Date of HFA Patent       Asthma and COPD Therapy            Discount Rate            CFC-based MDIs, Present
      Expiration          (million days of therapy)                                   Value in 2010 (billions)
----------------------------------------------------------------------------------------------------------------
2012                                              NA                            3%               -$0.09 - -$0.04
                                                     -----------------------------------------------------------
                        ............................                            7%               -$0.09 - -$0.04
----------------------------------------------------------------------------------------------------------------

2017                                         0.33-14                            3%                   $0.16-$0.91
                                                     -----------------------------------------------------------
                        ............................                            7%                   $0.12-$0.73
----------------------------------------------------------------------------------------------------------------

    The decreased use of MDIs may adversely affect some patients, but
we currently lack data that would allow us to characterize such effects
quantitatively. We also are unable to estimate quantitatively the
reductions in skin cancers, cataracts, and environmental harm that may
result from the reduction in CFC emissions by 310 to 365 tonnes during
these years. Although we cannot estimate quantitatively the public
health effects of the phase-out, based on a qualitative assessment, the
agency concludes that the benefits of this regulation justify its
costs.
    We state the need for the regulation and its objective in section
VI.B of this document. Section VI.C of the analysis provides background
on CFC depletion of stratospheric ozone, the Montreal Protocol, the MDI
market, and the health conditions that the seven moieties treat. We
analyze the benefits and costs of the rule, including effects on
government outlays, in section VI.D of this analysis. We assess
alternative dates in section VI.E of this analysis, and discuss our
sensitivity analysis in section VI.F. We discuss our conclusions in
section VI.G of this analysis. We present an analysis of the effects on
small business in a regulatory flexibility analysis in section VII of
this document.

B. Need for Regulation and the Objective of this Rule

    The objective of this final rule is to respond to the treaty
requiring the United States to reduce atmospheric emissions of ODSs,
specifically CFCs. CFCs and other ODSs deplete the stratospheric ozone
that protects the Earth from ultraviolet solar radiation. We are ending
the essential-use designation for ODSs used in MDIs containing
triamcinolone, metaproterenol, pirbuterol, cromolyn sodium, nedocromil
sodium, flunisolide, and albuterol and ipratropium in combination,
because we have concluded that adequate therapeutic alternatives are
available. Removing this essential-use designation will comply with
obligations under the Montreal Protocol and the Clean Air Act, thereby
reducing emissions that deplete stratospheric ozone.

C. Background

1. CFCs and Stratospheric Ozone
    During the 1970s, scientists became aware of a relationship between
the level of stratospheric ozone and industrial use of CFCs. Ozone
(O3), which causes respiratory problems when it occurs in
elevated concentrations near the ground, shields the Earth from
potentially harmful solar radiation when it is in the stratosphere.
Excessive exposure to solar radiation is associated with adverse health
effects such as skin cancer and cataracts, as well as adverse
environmental effects. Emissions of CFCs and other ODSs reduce
stratospheric ozone concentrations through a catalytic reaction,
thereby allowing more solar radiation to reach the Earth's surface.
Because of this effect and its consequences, environmental scientists
from the United States and other countries advocate ending all uses of
these chemicals.
2. The Montreal Protocol
    The international effort to craft a coordinated response to the
global environmental problem of stratospheric ozone depletion
culminated in the Montreal Protocol, an international agreement to
regulate and reduce production of ODSs. The Montreal Protocol is
described in section II.B.2 of this document. One hundred and ninety-
six countries are now Parties to the Montreal Protocol, and the overall
usage of CFCs has been dramatically reduced. In 1986, global
consumption of CFCs totaled about 1.1 million tonnes annually, and by
2004, total annual production had been reduced to 70,000 tonnes (Ref.
6). This decline amounts to more than a 90-percent decrease in
production and is a key measure of the success of the Montreal
Protocol. Within the United States, use of ODSs, and CFCs in
particular, has fallen sharply; production and importation of CFCs is
less than 1 percent of 1989 production and importation (Ref. 6).
    A relevant aspect of the Montreal Protocol is that production of
CFCs in any year by any country is banned after the phase-out date
unless the Parties to the Montreal Protocol agree to designate the use
for which the CFCs are produced as ``essential'' and approve a quantity
of new production for that use.
    Each year, each Party nominates the amount of CFCs needed for each
essential use and provides the reason why such use is essential.
Agreement on both the essentiality and the amount of CFCs needed for
each nominated use is reached by consensus at the annual Meeting of the
Parties.
3. Benefits of the Montreal Protocol
    EPA has generated a series of estimates of the environmental and
public health benefits of the Montreal Protocol (Ref. 7). The benefits
include reductions of hundreds of millions of nonfatal skin cancers, 6
million fewer fatalities due to skin cancer, and 27.5 million cataracts
avoided between 1990 and 2165 if the Montreal Protocol were fully
implemented. EPA estimated the value of these and related benefits to
equal $4.3 trillion in present value when discounted at 2 percent over
the period of 175 years. This amount is equivalent to about $7 trillion
in 2008 prices after adjusting for inflation between 1990 and 2008.
This estimate includes all benefits of total global ODS emission
reductions expected from the Montreal Protocol and is based on
reductions from a baseline scenario in which ODS emissions would
continue to grow for decades but for the Montreal Protocol.
4. Characteristics of COPD
    The seven CFC MDI products that are the subject of this final rule,
and Combivent in particular, may be used to treat COPD. While there is
some overlap between asthma patients and COPD patients, COPD
encompasses a group of diseases characterized by relatively fixed
airway obstruction associated with breathing-related symptoms (for
example, chronic coughing, expectoration, and wheezing). COPD is
generally associated with cigarette smoking and is extremely rare in
persons younger than 25.
    According to the National Health Interview Survey (NHIS), an
estimated 10 million adults in the United States

carried the diagnosis of COPD in 2007 (Ref. 8). The proportion of the
U.S. population with mild or moderate COPD has declined over the last
quarter century, although the rate of COPD in females increased
relative to males between 1980 and 2000. The most effective
intervention in modifying the course of COPD is smoking cessation.
Symptoms such as coughing, wheezing, and sputum production are treated
with medication.
5. Characteristics of Asthma
    These seven CFC MDIs, with the exception of Combivent, may be used
to treat asthma, a chronic respiratory disease characterized by
episodes or attacks of bronchospasm in addition to chronic airway
inflammation. These attacks can vary from mild to life-threatening and
involve shortness of breath, wheezing, coughing, or a combination of
symptoms. Many factors, including allergens, exercise, viral
infections, and others, may trigger an asthma attack.
    According to the 2007 NHIS, approximately 23 million adult patients
in the United States reported they had asthma (Ref. 9). The prevalence
of asthma decreases then increases with age, with the prevalence being
100 per 1,000 children ages 5-17 (5.3 million children) compared to 72
per 1,000 among adults ages 18-44 (8.0 million), 72 per 1,000 among
adults ages 45-64 (5.5 million), and 75 per 1,000 among adults age 65
and over (2.7 million) (Ref. 9).
    The NHIS reported that during 2007, about 12 million patients
reported experiencing an asthma attack in the course of the previous
year (Ref. 9, table 10). According to the National Ambulatory Medical
Care Survey, in 2006 there were 1.2 million outpatient asthma visits to
physician offices and hospital clinics and 1.7 million emergency room
visits (Ref. 9, table 19). According to the National Center for Health
Statistics, there were 444,000 hospital admissions for asthma in 2006
(Ref. 9, table 16) and 3,563 deaths (Ref. 9, table 1). The estimated
direct medical cost of asthma (hospital services, physician care, and
medications) was $14.7 billion (Ref. 9, table 20).
    While the prevalence of asthma has been increasing in recent years,
the CDC reports that the incidence of asthma (or the rate of new
diagnoses) has remained fairly constant since 1997 (Ref. 10). Non-
Hispanic Blacks, children under 17 years old, and females have higher
incidence rates than the general population and also have higher attack
prevalence. The CDC notes that although increases have occurred in the
numbers and rates of physician office visits, hospital outpatient
visits, and emergency room visits, these increases are accounted for by
the increase in prevalence. This phenomenon might indicate early
successes by asthma intervention programs that include access to
medications.
6. Current U.S. Market for CFC MDIs
    For the 12-month period ending June 2009, we estimate that sales of
these seven CFC MDIs provided roughly 300 million days of therapy,
sufficient to treat roughly 800,000 COPD and asthma patients for a full
year. We use days of therapy as a common metric because these MDIs vary
in the number of inhalations provided, and the number of inhalations
that the average user would use each day. We calculate the number of
days of therapy provided by each MDI as equal to the number of MDIs
sold, multiplied by the number of inhalations contained by the MDI,
divided by the recommended, or usual, daily inhalations described in
the MDI's physician labeling: [(Days of Therapy)=(MDIs)x(Inhalations/
MDI)/(Inhalations/day)]. We calculate MDI sales for each of the seven
products using data from IMS Health's National Sales Perspective (Ref.
11).
    We calculate the average price per day of therapy for a CFC MDI as
the total revenue derived from sales of that product in the 12 months
ending June 2009, as reported by IMS Health's National Sales
Perspective, divided by the number of days of therapy for that product:
[(Price/Day of Therapy)=(Total Sales)/(Total Days of Therapy)]. We use
the same method to calculate the average price per day of therapy for
the nine non-ozone depleting products we consider the most medically
appropriate alternatives to these seven CFC MDIs. We then estimate the
price premium (or savings) associated with alternatives as the
difference between price per day of the CFC product and price per day
of its most appropriate alternatives.

 Table 3.--Summary of CFC MDIs, Non-ODS Alternatives, and Expected Price
                  Changes per Day of Therapy (Ref. 11)
------------------------------------------------------------------------
                                      Price Premium per Day of Therapy
     CFC MDI           Non-ODS     -------------------------------------
                    Alternatives         Maximum            Minimum
------------------------------------------------------------------------
Aerobid           QVAR                          $1.06              $0.34
Aerobid-M         PULMICORT         .................  .................
                   TURBUHALER
                  FLOVENT HFA
                  ASMANEX
                   TWISTHALER
------------------------------------------------------------------------
Azmacort          QVAR                         -$1.10             -$1.82
                  PULMICORT
                   TURBUHALER
                  FLOVENT HFA
                  ASMANEX
                   TWISTHALER
------------------------------------------------------------------------
Alupent           PROAIR HFA                    $0.34             -$0.31
                  PROVENTIL HFA
                  VENTOLIN HFA
                  XOPENEX HFA
------------------------------------------------------------------------
Maxair            PROAIR HFA                   -$0.21             -$0.86
                  PROVENTIL HFA
                  VENTOLIN HFA
                  XOPENEX HFA
------------------------------------------------------------------------

Intal             QVAR                         -$1.34             -$2.06
                  PULMICORT
                   TURBUHALER
                  FLOVENT HFA
                  ASMANEX
                   TWISTHALER
------------------------------------------------------------------------
Tilade            QVAR                            N/A                N/A
                  PULMICORT
                   TURBUHALER
                  FLOVENT HFA
                  ASMANEX
                   TWISTHALER
------------------------------------------------------------------------
Combivent         ATROVENT HFA +                $1.30              $0.65
                   one of the
                   following:
                  PROAIR HFA
                  PROVENTIL HFA
                  VENTOLIN HFA
                  XOPENEX HFA
------------------------------------------------------------------------
Source: IMS Health, IMS National Sales Perspective (TM), 2009, extracted
  September 2009.

    Table 3 of this document shows each of the CFC MDIs that would no
longer be marketed, the therapeutic alternatives that users of these
CFC MDIs would be expected to purchase, and the range of differences in
price per day of therapy. For example, an Azmacort user would be
expected to switch to QVAR, PULMICORT TURBUHALER, FLOVENT HFA, or
ASMANEX TWISTHALER. The most expensive of these alternatives would cost
roughly $1.10 cents less per day of therapy, and the least expensive
would cost roughly $1.80 less per day of therapy. Combivent users would
be expected to switch to both ATROVENT HFA and one of four albuterol
HFA MDIs currently marketed. We make no attempt to forecast future
price changes, but note that recent changes in prices of CFC MDIs did
not differ systematically from the changes in prices of the proposed
alternatives. For our Maxair calculations, we have added the annual
purchase of a $30 spacer to the cost of switching to an alternative
therapy.
    If all users switched to the least expensive alternative therapy,
the average price for users of these seven CFC MDIs, weighted by the
number of days of therapy sold for each product in 2009, would increase
9 percent; if all users switched to the most expensive alternative
therapy, the average price per day of therapy would increase 28
percent. These price differences represent differences in average ex-
manufacturer prices across all distribution channels and do not
incorporate differences introduced by retail markups or off-invoice
discounts (Ref. 11).
    It is not possible to attribute these estimated price increases
exclusively to this final rule. These estimated price increases are
driven almost entirely by the large population of Combivent users
switching to both Atrovent Inhalation Aerosol and albuterol HFA MDIs,
which, together, are more expensive. Through 2003, the price for a day
of therapy with Combivent was roughly equal to the sum of a day of
therapy with Atrovent (the ipratropium CFC MDI which has been withdrawn
from the market) and a day of therapy with a generic albuterol CFC MDI.
After 2003, the price of a day of Combivent therapy rose to be roughly
equal to the sum of a day of therapy with Atrovent HFA and a day of
therapy with a generic albuterol CFC MDI, likely in anticipation of the
withdrawal of Atrovent from the market. The range of spending changes
for Combivent therapy alone is $150 million to $300 million; excluding
the effects of Combivent therapy, the range of spending changes is -$25
million to -$65 million.
    We estimate that these seven CFC MDIs are responsible for roughly
310 to 365 tonnes of CFC emissions annually. The CFC content of the
seven CFC MDIs ranges from about 6 to 20.5 grams per MDI. Multiplying
the total 2005 sales of each of the CFC MDIs by its CFC content, and
allowing for an additional 10 percent loss in the production process,
yields a total of 310 tonnes of CFC emissions annually, our low
estimate. Our recent data shows a decline in the use of the seven
moieties to be phased out, so our low estimate may overstate the
reduction in CFCs attributable to this final rule. The CFC MDI
manufacturers requested roughly 365 tonnes of CFCs for production of
the seven CFC MDIs for 2007, which we use for our high estimate.

D. Benefits and Costs of the Final Rule

    We estimate the benefits and costs of a government action relative
to a baseline scenario that in this case is a description of the
production, use, and access to these seven CFC MDIs in the absence of
this rule. In this section, we first describe such a baseline and then
present our analysis of the benefits of the final rule. We also present
an analysis of the most plausible regulatory alternative, given the
Montreal Protocol. Next we turn to the costs of the rule and to an
analysis of the effects on the Medicare and Medicaid programs.
1. Baseline Conditions
    We developed baseline estimates of future conditions to assess the
economic effects of prohibiting marketing of these seven CFC MDIs. MDIs
containing metaproterenol and nedocromil will be removed from the
market June 14, 2010. MDIs containing triamcinolone and cromolyn will
be removed from the market December 31, 2010. MDIs containing
flunisolide will be removed from the market June 30, 2011. Those
containing albuterol and ipratropium in combination and pirbuterol will
be removed from the market December 31, 2013.
    It is standard practice to use, as a baseline, the state of the
world without the rule in question, or where this implements a
legislative requirement, the world without the statute. For this final
rule, the Montreal Protocol makes the baseline assumption of indefinite
availability infeasible, but we can nevertheless use it as a point of
reference. In addition to the baseline of indefinite availability, we
also assess alternative phase-out dates for the final disappearance of
CFC products.

Throughout this baseline analysis, we assume that sufficient
inventories of CFCs are available to meet demand for these seven CFC
MDIs through the date they lose their essential-use designation and
that there will be sufficient therapeutic alternatives to meet demand
after they are removed from the market.
    However, in the absence of this final rule, the parties to the
Montreal Protocol would still have the ability to restrict access to
CFCs required for the manufacture of products using these seven
moieties. This final rule, in establishing a timetable for phasing out
these seven moieties, demonstrates a commitment to phasing out CFCs,
which reduces the need for the parties to act on their own. In a sense,
this final rule does not phase out these moieties, but attempts to
establish a phase-out timetable preferable to the one that the parties
to the Montreal Protocol might impose. The existence of a timetable
imposed by the parties to the Montreal Protocol different from this
final rule implies the costs detailed in the next section of this
analysis will accrue, although perhaps at a different time, regardless
of whether this final rule is enacted. The cost-benefit analysis
presented here would then apply to the withdrawal of the CFC-containing
products from the market rather than to the specific effects of the
final rule.
2. Benefits of the Final Rule
    The benefits of the final rule include environmental and public
health improvements from protecting stratospheric ozone by reducing CFC
emissions. Benefits also include expectations of increased returns on
investments in environmentally friendly technology, and continued
international cooperation to comply with the spirit of the Montreal
Protocol, thereby potentially reducing future emissions of ODSs
throughout the world.
    Failure to enact this final rule would leave the timetable for
phasing out these seven moieties in the hands of the parties to the
Montreal Protocol. As the parties to the Montreal Protocol would see
these drugs with therapeutic alternatives and no regulation in place to
commit to their phase-out, their likely response would be to deny the
provision of CFCs for their continued production and to do so in a way
that did not provide for an adequate transition period.
    a. Reduced CFC emissions. Market withdrawal of these seven CFC MDIs
will reduce emissions by approximately 310 to 365 tonnes of CFCs per
year. Current CFC inventories are substantial. Nominations for new CFC
production are generally approved by the Parties to the Montreal
Protocol 2 years in advance. The final rule would ban marketing of two
of the seven CFC MDIs after June 14, 2010, two more after December 31,
2010, one after June 30, 2011, and the remaining two after December 31,
2013.
    There is some uncertainty with respect to the amount of inventory
that will be available in the future, but we anticipate that existing
inventory will allow EPA, in consultation with FDA, to avoid nominating
additional CFC production for 2010 through 2013. Therefore, we estimate
the regulation will reduce CFC use by 310 to 365 tonnes per year after
the end of 2013, a benefit that will continue indefinitely.
    In an evaluation of its program to administer the Clean Air Act,
EPA has estimated that the benefits of controlling ODSs under the
Montreal Protocol are the equivalent of $7 trillion in 2008 dollars.
However, EPA's report provides no information on the total quantities
of reduced emissions or the incremental value per tonne of reduced
emissions. EPA derived its benefits estimates from a baseline that
included continued increases in emissions in the absence of the
Montreal Protocol. We have searched for authoritative scientific
research that quantifies the marginal economic benefit of incremental
emission reductions under the Montreal Protocol, but have found none
conducted during the last 10 years. As a result, we are unable to
quantify the environmental and human health benefits of reduced
emissions from this regulation. Such benefits, in any event, were
apparently included in EPA's earlier estimate of benefits of the Clean
Air Act.
    As a share of total global emissions, the reduction associated with
the elimination of the seven CFC MDIs represents only a fraction of 1
percent. Current allocations of CFCs for the seven MDIs account for
less than 0.1 percent of the total 1986 global production of CFCs (Ref.
6). Furthermore, current U.S. CFC emissions from MDIs represent a much
smaller, but unknown share of the total emissions reduction associated
with EPA's estimate of $7 trillion in benefits because that estimate
reflects future emissions growth that has not occurred.
    Although the direct benefits of this regulation are small relative
to the overall benefits of the Montreal Protocol, the reduced exposure
to UV-B radiation that will result from these reduced emissions will
help protect public health. The final rule will account for some small
part of the benefits estimated by EPA. However, we are unable to assess
or quantify specific reductions in future skin cancers and cataracts
associated with these reduced emissions.
    b. Returns on investment in environmentally-friendly technology.
Establishing a phase-out date prior to the expiration of patents on HFA
MDI technology not only rewards the developers of the HFA technology,
but also encourages other potential developers of ozone-safe
technologies. Furthermore, a phase-out date would preserve expectations
that the government protects incentives to research and develop ozone-
safe and other new technologies.
    Newly developed technologies to avoid ODS emissions have resulted
in more environmentally ``friendly'' air conditioners, refrigerants,
solvents, and propellants, but only after significant investments.
Several manufacturers have claimed development costs that total between
$250 million and $400 million to develop HFA MDIs and new propellant-
free devices for the global market (Ref. 12).
    These investments have resulted in several innovative products in
addition to HFA MDIs. For example, breath-activated delivery systems,
dose counters, dry-powder inhalers, and mini-nebulizers have also been
successfully marketed.
    c. International cooperation. The advantages of selecting a date
that maintains international cooperation are substantial because the
Montreal Protocol, like most international environmental treaties,
relies primarily on a system of national self-enforcement, although it
also includes a mechanism to address noncompliance. In addition,
compliance with its directives is subject to differences in national
implementation procedures. Economically less-developed nations, which
have slower phase-out schedules than developed nations, have emphasized
that progress in eliminating ODSs in developing nations is affected by
observed progress by developed nations, such as the United States. If
we had adopted a later phase-out date, other Parties could attempt to
delay their own control measures.
3. Costs of the Final Rule
    The final rule would increase spending for needed medicines used to
treat asthma and COPD. The social costs of the final rule include the
health benefits lost through decreased use of medicines that may result
from increased prices. We discuss the increased spending and then the
social costs in turn. We are unable to quantify the economic costs of
reducing the variety of marketed products from

which consumers, and their doctors, can choose. Because we lack data
that would enable us to measure the effects of a decreased number of
products from which to choose, in this analysis we only quantify the
effects on spending.
    In the absence of this regulation, we would expect 300 million days
of therapy with these seven CFC MDIs to be sold annually. With this
regulation, patients who would have used any of these seven CFC MDIs
are expected to switch to one of several other products as described in
table 3 of this document. Depending on whether asthma and COPD patients
use the most or least expensive of alternatives, private, third-party,
and public expenditures on inhaled medicines would increase by roughly
$90 million to $280 million per year. These expenditure increases will
be driven almost exclusively by Combivent users changing to both
Atrovent and one of four available albuterol HFA products. With most,
perhaps all, of this increase coming from estimated increased spending
on albuterol HFA products, what happens to the prices of albuterol
products will largely determine the change in overall spending. To the
extent that expenditures rise, these higher costs would continue until
lower-priced non-ODS substitutes appear on the market. For many of
these products it is difficult to predict when this might occur. With
the exception of albuterol CFC MDIs, generic versions of prescription
MDIs and DPIs for treatment of asthma and COPD have not been
introduced, despite the expiration of the patents on many of the
innovator products. However, the market for albuterol MDIs has a clear
history of generic competition. A previous rulemaking (70 FR 17168,
April 4, 2005) removed albuterol CFC MDIs, including generic albuterol
CFC MDIs, from the market on December 31, 2008. If these cheaper
generic albuterol MDIs had been able to remain on the market, the
expected cost of switching from Combivent to both Atrovent and an
albuterol HFA MDI would be essentially eliminated. Because expenditure
increases resulting from this final rule stem almost exclusively from
the transition away from Combivent, such increases would most likely be
eliminated with the introduction of generic albuterol HFA MDIs to the
market. There are multiple patents listed in ``Approved Drug Products
with Therapeutic Equivalence Evaluations'' (Orange Book) for albuterol
HFA MDIs, expiring from late 2009 to beyond 2020, creating a wide range
of possible dates for generic entry. In the proposed rule, we assumed
potential entry in 2010 and 2017. As moieties will not start to be
removed from the market until June 14, 2010, generic entry in 2010
would eliminate almost all of the estimated costs of the transition.
For this final rule, we use 2012 and 2017 for assumed entry of generic
substitutes for current branded albuterol MDI products. One recent
study predicted the introduction of a generic albuterol HFA MDI in 2012
(Ref. 13). For the year 2010, we include only the impact of Alupent and
Tilade and for the years 2011 through 2013, we include in the analysis
the impact of all moieties except Combivent and Maxair. Removing those
five moieties from the market results in a change in annual private,
third-party, and public expenditures of roughly -$20 million to -$50
million. Of course, unforeseen introduction of alternative therapies
could reduce any expected increases in expenditures.
    These increased expenditures represent, to some extent, transfers
from consumers and third-party payers, including State and Federal
Governments, to pharmaceutical manufacturers, patent holders, and other
residual claimants. However, to some extent, increased expenditures
represent purchases of products that are more costly to manufacture and
bring to market. We are unable to estimate the fraction of the
increased expenditures that constitute societal costs.
    We estimate that the average price increases resulting from market
withdrawal of less expensive CFC MDIs could reduce use of inhaled
therapy by a range of 0.20 to 4.2 million days annually, equivalent to
roughly 0.5 to 12 thousand patient years of therapy. The impact of this
reduction on health outcomes is too uncertain to quantify given
available data. Some patients, however, respond to price increases for
medications for chronic conditions in ways that may adversely affect
their health.
    A recent article found that, ``copayment increases led to increased
use of emergency department visits and hospital days for the sentinel
conditions of diabetes, asthma, and gastric acid disorder: predicted
annual emergency department visits increased by 17 percent and hospital
days by 10 percent when copayments doubled'' (Ref. 14). However, the
article proceeds to characterize these results as ``not definitive.''
This finding suggests that increased prices for medicines may lead to
some adverse public health effects among the users of these seven CFC
MDIs.
    Another article found that, ``a single inhaler containing both
ipratropium and albuterol can increase compliance and decrease
respiratory morbidity and charges over and above the effects achieved
with separate inhalers for these 2 agents'' (Ref. 5). The article found
that access to single inhaler therapy was associated with a 17 percent
reduction in monthly costs. This finding suggests that some current
users of Combivent may suffer adverse health consequences because of
compliance issues associated with using multiple inhalers. This
preliminary evidence is insufficient to permit us to quantify adverse
public health effects. We use expected reductions in days of therapy
purchased as a surrogate measure of the impact.
    Our approach to estimating the effects of this final rule assumes
that the primary effect of an elimination of these seven CFC MDIs from
the market would be an increase in the average price of MDI and DPI
therapy. Given the price increase expected, we have projected how the
overall quantity of MDI and DPI therapy consumed may decline as a
result of the increase in price. We assume that the reduction in the
use of MDI and DPI therapy attributable to this rule can be calculated
as the product of the sensitivity of use with respect to the price
increase, the baseline use of these seven CFC MDIs among price-
sensitive patients, and the price increase in percentage terms. We
discuss these in turn.
    We have no information about how consumers react to increases in
the price of these seven forms of CFC MDIs in particular, much less to
what amounts to a compulsory switch to different, more expensive drugs.
Economists have, however, estimated the response of consumers to higher
insurance copayments for drugs in general. Goldman et al. estimate
price elasticities in the range of -0.33 (for all anti-asthmatic drugs)
to -0.22 (for anti-asthmatic drugs among patients with chronic asthma),
implying that a 10 percent increase in insurance copayments apparently
leads to a reduction in use of between 2.2 and 3.3 percent (Ref. 14),
but the authors report that there is wide variance based on the
availability of over-the-counter substitutes. For example, for drugs
with no over-the-counter substitutes--a set that includes all seven of
these CFC MDIs--the reported price elasticity was -0.15 (Ref. 14, p.
2348). Drugs included as anti-asthmatics in this study include anti-
cholinergics, anti-inflammatory asthma agents, leukotriene modulators,
oral steroids, steroid inhalers, sympathomimetics, and xanthines. We
have used price elasticities of between -0.15 and -0.33 to estimate the
potential effect of price increases on demand.

    To derive an estimate of the quantity of medicines not sold as a
result of this rule, we need an estimate of the baseline use of these
seven CFC MDIs by price-sensitive consumers. To do so, we distinguish
between the insured and the insured the uninsured. Based on IMS data,
we estimate that asthma and COPD patients receive roughly 300 million
days of therapy each year in the form of these seven CFC MDIs (Ref.
11). If users of these products are uninsured in proportion to the
share of uninsured in the overall U.S. population (15.4 percent) (Ref.
15), then uninsured asthma and COPD patients receive roughly 46 million
days of therapy [(300 million)x(15.4 percent)] in the form of these
seven CFC MDIs, equivalent to roughly 126 thousand patient years.
    Increases in the price of therapy, however, will mostly affect
Combivent users with COPD. For Combivent users, we use the two major
sources of decreased use, price increases for the uninsured and
increased copayments for the insured, to calculate a very rough
estimate of reduced patient days. According to the 2007 NHIS, 1.8
million individuals over the age of 65 have bronchitis and 1.7 million
have emphysema. Data from the 2007 NHIS also suggest that approximately
31 percent of adults with emphysema also have chronic bronchitis (Ref.
8, Figure 2). Assuming this ratio holds for those over 65, there are
about 3.1 million individuals over the age of 65 with COPD (3.6 million
with either diagnosis--500,000 with both). This number of patients
represents approximately 30 percent of the 10 million adults with COPD.
Assuming all of those over 65 with COPD and about 85 percent of those
under 65 have some form of drug insurance means that about 9.1 million
of those with COPD are covered by drug insurance and 1.1 million are
not. The uninsured estimate represents 10 percent of the population
with COPD, so there would be approximately 23.7 million days of
uninsured therapy for Combivent annually.
    The midpoint of the high and low price increase estimates for
Combivent is 27 percent. Assuming uninsured consumers face a 27 percent
price increase and have an elasticity of 0.15, there would be among the
uninsured an annual reduction in therapy of approximately 960,000 days
after Combivent is removed from the market.
    We do not know the characteristics of the prescription drug
insurance held by those with COPD, but recognize that many of the 9.1
million insured face per-product copayments. These copayments will
likely be a smaller fraction of income for the insured than are the
price increases for the uninsured, so we assume the demand to be less
elastic. Assuming 214 million annual days of insured therapy and an
elasticity of 0.075, a 100 percent increase in the size of copayments
would imply a 7.5 percent reduction in quantity demanded, or 16.0
million annual days of therapy foregone. Thus, a very rough estimate of
a change in quantity of Combivent demanded in response to a price
increase would be 17 million days of therapy (960,000 + 16.0 million).
The appearance of a reformulated non CFC product combining albuterol
and ipratroprium would avert the 16 million lost days of therapy
potentially associated with the co-payment effect.
    Finally, for an overall average estimate of the effects of the
average price increases, we estimate that users of these seven CFC MDIs
face an average price increase of between 9 and 28 percent per day of
therapy after all seven moieties have been removed from the market,
depending on whether asthma and COPD patients switch to the most or
least expensive of the proposed alternatives detailed in table 3 of
this document. We calculate the low and high estimates as the average
percentage price change of the least and most expensive alternatives to
each of the seven CFC MDIs, weighted by the number of days of therapy
of CFC MDIs sold for the twelve months ending June 2009. Excluding
Combivent, users of the other six CFC MDIs would face prices somewhere
between 15 and 41 percent lower. Excluding Combivent and Maxair, the
users of the other five CFC MDIs would face prices between 17 and 39
percent lower.
    We combine different measures of price elasticities (-0.15 to -
0.33), the size of the uninsured CFC MDI market (15 to 46 million days
of therapy), and estimated price increases (9 percent to 28 percent) to
estimate the impact of average price increases on use. For example,
assuming a price elasticity of -0.15 and 15 million days of therapy
sold to the uninsured annually, a 9 percent price increase would reduce
demand for inhaled therapy by the uninsured by roughly 200,000 days of
therapy annually. By contrast, assuming a price elasticity of -0.33 and
46 million days of therapy sold to the uninsured annually, a 28 percent
price increase would reduce uninsured demand by roughly 4 million days
of therapy [(46 million days) x (-0.33 elasticity) x (28 percent price
increase) = 4 million days of therapy]. We recognize that because of
varying measures of the size of the CFC MDI market for the uninsured,
uncertainty about the magnitude of price increases, and consumer
response, the true impact of the rule could fall outside this range.
    We recognize that as a result of this rulemaking, patients will
lose access to products they prefer to use. This regulatory action will
constrain consumption decisions, forcing patients to switch to
substitute products they would not otherwise choose to consume,
resulting in consumer welfare loss. We lack information to reliably
estimate the social cost associated with the loss of preferred
products, but we recognize such a cost exists.
4. Effects on Medicare and Medicaid
    According to the 2006 Medical Expenditure Panel Survey (MEPS),
Medicaid pays for 13.8 of the expenses attributable to COPD and asthma.
Medicare pays for 30.6 percent of these expenses. Assuming these MEPS
payment estimates for Medicaid and Medicare apply to the incremental
expenses from switching to HFA MDIs, this final rule will increase
annual Federal Medicaid spending between $12 and $39 million. We
estimate that total spending by Medicare and Medicare beneficiaries
will increase between $27 million to $87 million annually. The
estimated annual impacts would apply after 2013, after all seven
moieties have been phased out, and continue until the HFA technology
loses patent protection. Where the impact would occur within these
broad ranges would depend on the alternative therapies chosen.
    For the year 2010, the change in Medicaid and Medicare spending
would be associated with the costs of switching from Tilade and
Alpuent. Medicaid spending would change somewhere between a decline of
$50,000 and an increase of $60,000. The change in Medicare spending
would be between a decline of $110,000 and an increase of $130,000. For
the years 2011 through 2013, we include the impacts associated with all
seven moieties except Maxair and Combivent. In those years, annual
Medicaid spending would fall by an estimated $2.9 to $6.7 million.
Medicare spending would decline between $6.3 and $15 million annually.
    The present discounted value of the impact of the regulation on
Medicaid expenses, assuming HFA patent expiration at the end of 2017 is
from $20 million to $100 million at a 7 percent discount rate and from
$20 million to $130 million at 3 percent. For Medicare, the present
disounted value is from $40 million to $220 million at a 7 percent
discount rate and from $50 million to $280 million at 3 percent.
Assuming the HFA technology loses patent protection

at the end of 2012, the change in Medicaid expenditures is a present
discounted -$12 million to -$5 million at 7 percent and -$13 million to
-$5 million at 3 percent. For Medicare, the change in expenditures is -
$30 million to -$10 million at a 7 percent discount rate and -$30
million to -$10 million at a 3 percent rate.
    We are unable to estimate the extent to which Medicare cost
increases will be paid by Medicare beneficiaries themselves or by the
Federal Government. Whether individuals or the Federal Government will
pay depends on beneficiaries' aggregate drug spending in a given year
and the Medicare Part D plan they choose. Moreover, as we expect the
characteristics of Medicare Part D and the types of plans chosen by
beneficiaries to continue to evolve in coming years, past payment
statistics may not reflect future conditions. These are rough
estimates.

E. Alternative Phase-Out Dates

    We consider the impacts of the alternative phase-out date of
December 31, 2010, for the five moieties not already phased out at the
end of 2010. The expense information in table 4 shows such an earlier
phase-out would increase expenditures and further decrease the use of
asthma and COPD therapy. Moreover, an earlier phase-out data would be
impractical due to the time necessary to complete the regulatory
process and to the risk of MDI shortages if the market has insufficient
time to switch from CFC to HFA MDIs. A phase-out date set too far in
the future, however, would be incompatible with the timetable set by
the Montreal Protocol. This leaves a narrow window for consideration.

         Table 4.--Summary of Impacts of a December 31, 2010 Phase-Out Relative to HFA Patent Expiration
----------------------------------------------------------------------------------------------------------------
                                                 Possible Decreases                             Increases in
                                                in Use of Asthma and                        Expenditures on CFC-
         Date of HFA Patent Expiration              COPD Therapy          Discount Rate      based MDIS, Present
                                                  (million days of                              Value in 2009
                                                      therapy)                                   (billions)
----------------------------------------------------------------------------------------------------------------
2012                                                        0.40-8.5                    3%           $0.17-$0.54
                                                                     -------------------------------------------
                                                ....................                    7%           $0.16-$0.51
----------------------------------------------------------------------------------------------------------------
2017                                                          1.4-30                    3%           $0.55-$1.77
                                                                     -------------------------------------------
                                                ....................                    7%           $0.48-$1.53
----------------------------------------------------------------------------------------------------------------

F. Sensitivity Analyses

    The estimated impacts of this final rule summarized in table 5 of
this document incorporate a range of estimates about the price
increases consumers and other payers will face, the size of the
affected market and how consumers will respond to price increases. This
range represents the full uncertainty range for the estimated effects
of this final rule. The full range incorporates the ranges of estimates
for the individual uncertain variables in the analysis.
    In each section of the document, we show the ranges associated with
each major uncertain variable. To estimate reduced use of inhaled
medications, we estimate 15 million to 46 million days of therapy are
used by uninsured individuals annually. We estimate that these
consumers will face price increases in switching from CFC to HFA MDIs
from 9 to 28 percent per day of therapy, depending on whether they
switch to the most expensive or least expensive of available
alternatives. We use price elasticities ranging from -0.15 to -0.33 to
estimate how consumers will reduce their MDI use in response to price
increases.
    Similarly, estimates of the impact of the final rule on public and
private spending depend on the overall size of the CFC MDI market and
how much prices increase. We estimate the consumers purchase roughly
300 million days of therapy in the form of CFC MDIs annually, and that
prices will increase 9 to 28 percent depending on whether they switch
to the most expensive or least expensive of available alternatives. If
we exclude Combivent from the calculation, the expected price effects
range from a 15 to 41 percent decrease, depending on whether they
switch to the most expensive or least expensive of available
alternatives. If we also exclude Maxair, expected price effects range
from a 17 to 39 percent decrease.

G. Conclusion

    Limits in available data prevent us from quantifying the costs and
benefits of the final rule and weighing them in comparable terms. The
benefits of international cooperation to reduce ozone emissions are
potentially enormous but difficult to attribute to any of the small
steps, such as this final rule, that make such cooperation effective.
As discussed above in detail, the benefits of the final rule include
environmental and public health improvements from protecting
stratospheric ozone by reducing CFC emissions. Benefits also include
expectations of increased returns on investments in environmentally
friendly technology, reduced risk of unexpected disruption of supply of
CFC MDIs, and continued international cooperation to comply with the
spirit of the Montreal Protocol, thereby potentially reducing future
emissions of ODSs throughout the world. This final rule could
potentially cost public and private consumers of CFC MDIs hundreds of
millions of dollars annually, but it is difficult to link these costs
to adverse public health outcomes.

                                                           Table 5.--Summary Accounting Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                Primary                                    ------------------------------------------------
         Category              Estimate      Low Estimate    High Estimate                                      Period                  Notes
                                                                             Year Dollars    Discount Rate      Covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------

Annualized Quantified       ..............  ..............  ..............  ..............              7%          Annual  Reduction of CFC emissions
                                                                                by 310-365 tonnes.
                           ------------------------------------------------------------------------------------------------
                            ..............  ..............  ..............  ..............              3%          Annual  ............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualitative                                                                 ..............  ..............  ..............  Compliance with Montreal
                                                                                Protocol. Increased
                                                                                investment in
                                                                                environmentally friendly
                                                                                technologies. International
                                                                                cooperation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized        ..............  -$12 million- -   $16 million-            2010              7%          Annual  Consumers lose access to
 $millions/year                               $4.9 million     $98 million                                                   therapies that, but for
                                                                                this action, would have
                                                                                been their preferred
                                                                                products. Uses 10-year
                                                                                annualization. Range of
                                                                                estimates captures
                                                                                underlying uncertainty. Low
                                                                                estimate assumes 2012 HFA
                                                                                patent expiration. High
                                                                                estimate assumes 2017 HFA
                                                                                patent expiration. No
                                                                                central tendency. These
                                                                                costs are transfers from
                                                                                payers to drug companies
                                                                                and are largely
                                                                                attributable to the
                                                                                withdrawal of generic
                                                                                albuterol which occurred
                                                                                under another rulemaking.
                           ------------------------------------------------------------------------------------------------
                            ..............  -$11 million- -   $19 million-            2010              3%          Annual  ............................
                                              $4.5 million    $100 million
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualitative                                                                 ..............  ..............  ..............  Consumers may respond to
                                                                                higher prices by forgoing
                                                                                medication, which could
                                                                                result in adverse health
                                                                                outcomes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers
--------------------------------------------------------------------------------------------------------------------------------------------------------

Federal Annualized          ..............  -$5.2 million-   $6.9 million-            2010              7%          Annual  Medicare plus Medicaid, 10-
 Monetized $millions/year                    -$2.2 million     $43 million                                                   year annualization. Low
                                                                                estimate assumes 2012 HFA
                                                                                patent expiration. High
                                                                                estimate assumes HFA patent
                                                                                expires end of 2017. Rough
                                                                                approximation.
                           ------------------------------------------------------------------------------------------------
                            ..............  -$4.7 million-   $8.3 million-            2010              3%          Annual  ............................
                                             -$2.0 million     $46 million
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To                                  From: U.S. Government
                                                To: Drug manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small Business                                                                                A single drug manufacturer
                                                                                may meet threshold for
                                                                                small business. Affected
                                                                                entities are otherwise not
                                                                                small.
--------------------------------------------------------------------------------------------------------------------------------------------------------

VII. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. For purposes of determining whether a substantial
number of small entities are affected by this rule, the industry
includes all manufacturers of pharmaceutical products in the United
States. According to the U.S. Department of Commerce, the industry of
``pharmaceutical preparation manufacturers'' includes 901
establishments controlled by 723 companies (Ref. 3). Of these
establishments, 822 have fewer than 500 employees.
    This rule significantly affects firms that manufacture the seven
CFC MDIs. Because there is, at most, a single small CFC MDI
manufacturer that would be significantly affected by the rule, in an
industry with hundreds of small entities, the agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities. Additional discussion of our analysis can be
found in section IV, Comments on the 2007 Proposed Rule, which responds
to Comment 16 submitted by Graceway.

VIII. The Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IX. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

X. References

    The following references have been placed on display in the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, and may be seen by interested persons between 9 a.m. and 4
p.m., Monday through Friday.

    1. Expert Panel Report 3: Guidelines for the Diagnosis and
Management of Asthma (EPR-3), NIH Publication No. 07-4051, Bethesda,
MD, U.S. Department of Health and Human Services; National
Institutes of Health; National Heart, Lung, and Blood Institute;
National Asthma Education and Prevention Program, 2007, available at
http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm.
    2. Hess, Dean R., ``Aerosol Delivery Devices in the Treatment of
Asthma,'' Respiratory Care, 53, 2008: 699-723.
    3. United States, Department of Commerce, Census Bureau;
Economics and Statistics Administration, Pharmaceutical Preparation
Manufacturing: 2002, Washington, D.C., U.S. Census Bureau, 2004.
    4. Envrios March, Study on the Use of HFCs for Metered Dose
Inhalers In the European Union: Final report following submission to
the ECCP (European Commission Climate Change Policy Group), Republic
of Geneva: International Pharmaceutical Aerosol Consortium, December
2000.
    5. Chrischilles, Elizabeth, Daniel Gilden, Joanna Kubisiak,
Linda Rubenstein, and Hemal Shah, ``Delivery of Ipratropium and
Albuterol Combination Therapy for Chronic Obstructive Pulmonary
Disease: Effectiveness of a Two-in-one Inhaler Versus Separate
Inhalers,'' The American Journal of Managed Care, 8 (2002): 902-11.
    6. United Nations Environmental Programme, Production and
Consumption of Ozone-Depleting Substances: 1986-2004, 2005.
    7. U.S. Environmental Protection Agency, ``The Benefits and
Costs of the Clean Air Act: 1990-2010'' (http://www.epa.gov/air/
sect812/1990-2010/fullrept.pdf, November 1999.
    8. American Lung Association, ``Trends in COPD (Chronic
Bronchitis and Emphysema): Morbidity and Mortality,'' Epidemiology &
Statistics Unit, Research and Scientific Affairs, February 2010.
    9. American Lung Association, ``Trends in Asthma Morbidity and
Mortality,''

Epidemiology & Statistics Unit, Research and Scientific Affairs,
January 2009.
    10. Mannino, D. M. et al., ``Surveillance for Asthma--United
States, 1980-1999,'' Morbidity and Mortality Weekly Report,
51(SS01):1-13, March 29, 2002.
    11. Analysis completed by FDA based on information provided by
IMS Health, IMS National Sales Perspective (TM), 2009, extracted
September 2009. These data can be purchased from IMS Health. Please
send all inquiries to: IMS Health, Attn: Brian Palumbo, Account
Manager, 660 West Germantown Pike, Plymouth Meeting, PA 19462.
    12. Rozek, R. P., and E. R. Bishko, ``Economic Issues Raised in
the FDA's Proposed Rule on Removing the Essential-Use Designation
for Albuterol MDIs,'' National Economic Research Associates, August
13, 2004 (FDA Docket No. 2003P-0029/C25).
    13. Hendeles, L. G, L. Colice, and R. J. Meyer, ``Withdrawal of
Albuterol Inhalers Containing Chlorofluorocarbon Propellants,'' New
England Journal of Medicine, 356:1344-1351, March 29, 2007.
    14. Goldman, D. P. et al., ``Pharmacy Benefits and the Use of
Drugs by the Chronically Ill,'' The Journal of the American Medical
Association, 291:2344-2350, May 19, 2004.
    15. DeNavas-Walt, C., B. D. Proctor, and J. C. Smith, U.S.
Census Bureau, Current Population Reports, P60-236(RV), Income,
Poverty, and Health Insurance Coverage in the United States: 2008,
Table 7, p. 21, 2009.

List of Subjects in 21 CFR Part 2

    Administrative practice and procedure, Cosmetics, Drugs, Foods.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Clean
Air Act and under authority delegated to the Commissioner of Food and
Drugs, after consultation with the Administrator of the Environmental
Protection Agency, 21 CFR part 2 is amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

0
1. The authority citation for 21 CFR part 2 continues to read as
follows:

    Authority:  15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342,
343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42
U.S.C. 7671 et seq.

Sec.  2.125  [Amended]

0
2. Effective June 14, 2010, in Sec.  2.125, remove and reserve
paragraphs (e)(2)(iii) and (e)(4)(vii).

Sec.  2.125  [Amended]

0
3. Effective December 31, 2010, in Sec.  2.125, remove and reserve
paragraphs (e)(1)(v) and (e)(4)(iv).

Sec.  2.125  [Amended]

0
4. Effective June 30, 2011, in Sec.  2.125, remove and reserve
paragraph (e)(1)(iii).

Sec.  2.125  [Amended]

0
5. Effective December 31, 2013, in Sec.  2.125, remove and reserve
paragraphs (e)(2)(iv) and (e)(4)(viii).

    Dated: April 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8467 Filed 4-13-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: April 14, 2010 (Volume 75, Number 71)]
[Notices]
[Page 19453-19454]
[DOCID:fr14ap10-118]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment

period was published on November 24, 2009 [74 FR 61405-61406].

DATES: Comments must be submitted on or before May 14, 2010.

FOR FURTHER INFORMATION CONTACT: Shirlene Ball at the National Highway
Traffic Safety Administration, Office of the Chief Information Officer,
(NPO-400), 1200 New Jersey Ave., SE., W51-217, NPO 420, Washington, DC
20590. Mrs. Ball's telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Air Bag Deactivation.
    OMB Number: 2127-0588.
    Type of Request: Extension of a currently approved information
collection.
    Abstract: If a private individual or lessee wants to install an air
bag on-off switch to turn-off either or both frontal air bags, they
must complete Form OMB 2127-0588 to certify certain statements
regarding use of the switch. The dealer or business must, in turn,
submit the completed forms to NHTSA within seven days. The submission
of the completed forms by the dealers and repair business to NHTSA, as
required, will serve the agency several purposes. They will aid the
agency in monitoring the number of authorization requests submitted and
the pattern in claims of risk groups membership. The completed forms
will enable the agency to determine whether the dealers and repair
business are complying with the terms of the exemption, which include a
requirement that the dealers and repair businesses accept only fully
completed forms. Finally, submission of the completed forms to the
agency will promote honesty and accuracy in the filling out of the
forms by vehicle owners. The air bag on-off switches are installed only
in vehicles in which the risk of harm needs to be minimized on a case-
by-case basis.
    Affected Public: Private individuals, fleet owners and lessees,
motor vehicle dealers, repair business.
    Estimated Total Annual Burden: 3,750 hours.
    Estimated Number of Respondents: 7,500.

ADDRESSES: Send comments, within 30 days, to: Chandana Achanta, Desk
Officer, Office of Management and Budget, Office of Information and
Regulatory Affairs, Attention: by fax at<PHONE_NUMBER>; by mail at
Room 10235, 725-17th Street, NW., Washington, DC 20503; or at OIRA_
<EMAIL_ADDRESS>    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Departments estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A Comment to OMB is most effective if OMB
receives it within 30 days of publication.

    Issued in Washington, DC, on April 6, 2010.
Kevin Mahoney,
Director, Corporate Customer Services.
[FR Doc. 2010-8488 Filed 4-13-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 124 (Tuesday, June 28, 2016)]
[Rules and Regulations]
[Pages 41815-41817]
[FR Doc No: 2016-15239]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0538]
RIN 1625-AA00

Safety Zone; Allegheny River Mile 0-0.5, Monongahela River Mile
0-0.5, Ohio River Mile 0-0.5, Pittsburgh, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Allegheny River, Monongahela River, and Ohio
River from mile 0.0-0.5 on each of the three rivers. The safety zone is
needed to protect personnel, vessels, and the marine environment from
potential hazards created from a barge-based fireworks display. Entry
of vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Pittsburgh.

DATES: This rule is effective on July 9, 2016 from 8:30 p.m. until
10:30 p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0538 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh,
U.S. Coast Guard, at telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
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 the Coast Guard received notice on
June 8, 2016 that this fireworks display would take place. After
receiving and fully reviewing the event information, circumstances, and
exact location, the Coast Guard determined that a safety zone is
necessary to protect personnel, vessels, and the marine environment
from potential hazards created from a barge-based fireworks display on
the navigable waterway. It would be impracticable to complete the full
NPRM process for this safety zone because it needs to be established by
July 9, 2016. The fireworks display has been advertised and the local
community has prepared for the event.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register. Delaying this rule
would be contrary to public interest of ensuring the safety of
spectators and vessels during the event. Immediate action is necessary
to prevent possible loss of life and property during the hazards
created by a barge-based fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Pittsburgh (COTP) has determined that a
safety zone is needed on July 9, 2016. This rule is needed to protect
personnel, vessels, and the marine environment from potential hazards
created from a barge-based fireworks display.

IV. Discussion of the Rule

    This rule establishes a safety zone on July 9, 2016 from 8:30 p.m.
until 10:30 p.m. The safety zone will cover all navigable waters on the
Allegheny River, Monongahela River, and Ohio River from mile 0.0-0.5 on
each of the three rivers. The duration of the safety zone is intended
to protect personnel, vessels, and the marine environment from
potential hazards created from a barge-based firework display. No
vessel or person will be permitted to enter 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. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. This safety zone impacts a
small portion of the waterway on each of the three rivers and for a
limited duration of two hours. Vessel traffic will be informed about
the safety zone through local notices to mariners. Moreover, the Coast
Guard will issue broadcast botices to mariners

via VHF-FM marine channel 16 about the zone and the rule allows vessels
to seek permission to transit the zone.

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
contact 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

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 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
Management Directive 023-01 and Commandant Instruction M16475.lD, 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 two hours that will prohibit entry
to the Allegheny River, Monongahela River, and Ohio River from mile
0.0-0.5 on each of the three rivers, during the barge-based firework
event. It is categorically excluded from further review under paragraph
34 (g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact 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

    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:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0538 to read as follows:

Sec.  165.T08-0538  Safety Zone, Allegheny River, Monongahela River,
and Ohio River, Pittsburgh, PA.

    (a) Location. The following area is a safety zone: Allegheny River,
Monongahela River, and Ohio River from mile 0.0-0.5 on each of the
three rivers.
    (b) Enforcement. This rule will be enforced, from 8:30 p.m. until
10:30 p.m. on July 9, 2016.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Pittsburgh or a designated
representative.
    (2) Persons or vessels requiring entry into or passage through the
zone must request permission from the Captain of the Port Pittsburgh or
a designated representative. The Captain of the Pittsburgh
representative may be contacted at<PHONE_NUMBER>.
    (3) All persons and vessels shall comply with the instructions of
the Captain of the Port Pittsburgh or their designated representative.
Designated Captain of the Port representatives include United States
Coast Guard commissioned, warrant, and petty officers.

    (d) Information Broadcasts. The Captain of the Port Pittsburgh or a
designated representative will inform the public through broadcast
notices to mariners of the enforcement period for the safety zone as
well as any changes in the planned schedule.

L. Mcclain, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Pittsburgh.
[FR Doc. 2016-15239 Filed 6-27-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]
[Page 73070-73071]
[DOCID:fr29no10-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP10-493-000]

Empire Pipeline, Inc.; Notice of Availability of the
Environmental Assessment for the Proposed Tioga County Extension
Project

November 19, 2010.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the Tioga
County Extension Project proposed by Empire Pipeline, Inc. (Empire) in
the above-referenced docket. Empire requests authorization to construct
and replace pipeline facilities to provide an additional 350,000
dekatherms per day of natural gas capacity from new producer
interconnections in Pennsylvania to new interconnections on its
pipeline system and on Tennessee Gas Pipeline Company's system in New
York.
    The EA assesses the potential environmental effects of the
construction and operation of the Tioga County Extension Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). The FERC staff concludes that approval of the proposed
project, with appropriate mitigating measures, would not constitute a
major Federal action significantly affecting the quality of the human
environment.
    The New York State Department of Environmental Conservation, New
York State Department of Agriculture and Markets, and the U.S. Army
Corps of Engineers participated as cooperating agencies in the
preparation of the EA. Cooperating agencies have jurisdiction by law or
special expertise with respect to resources potentially affected by the
proposal and generally participate in the NEPA analysis.
    The proposed Tioga County Extension Project includes the following
facilities:
     Construction of approximately 14.9 miles of new 24-inch-
diameter pipeline in Tioga County, Pennsylvania and Steuben County, New
York;
     Replacement of approximately 1.4 miles of existing 24-
inch-diameter pipeline in Ontario County, New York;
     Construction of a new interconnect with Tennessee Gas
Pipeline Company in Ontario County, New York; and
     Construction of miscellaneous pipeline modifications and
appurtenant facilities at the existing Oakfield Compressor Station in
Genessee County, New York.
    The EA has been placed in the public files of the FERC and is
available for public viewing on the FERC's Web site at http://
www.ferc.gov using the eLibrary link. A limited number of copies of the
EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street,
NE., Room 2A, Washington, DC 20426.<PHONE_NUMBER>.
    Copies of the EA have been mailed to Federal, State, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the project area; and parties to
this proceeding.

    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that your comments are properly recorded and considered prior to
a Commission decision on the proposal, it is important that the FERC
receives your comments in Washington, DC, on or before December 20,
2010.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
project docket number (CP10-493-000) with your submission. The
Commission encourages electronic filing of comments and has dedicated
eFiling expert staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at http://
www.ferc.gov under the link to Documents and Filings. An eComment is an
easy method for interested persons to submit brief, text-only comments
on a project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at http://
www.ferc.gov under the link to Documents and Filings. With eFiling, you
can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling users must first create an
account by clicking on ``eRegister.'' You will be asked to select the
type of filing you are making. A comment on a particular project is
considered a ``Comment on a Filing''; or
    (3) You may file a paper copy of your comments at the following
address: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Room 1A, Washington, DC 20426.
    Although your comments will be considered by the Commission, simply
filing comments will not serve to make the commenter a party to the
proceeding. Any person seeking to become a party to the proceeding must
file a motion to intervene pursuant to Rule 214 of the Commission's
Rules of Practice and Procedures (18 CFR 385.214).\1\ Only intervenors
have the right to seek rehearing of the Commission's decision.
---------------------------------------------------------------------------

    \1\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC or on the
FERC Web site (http://www.ferc.gov) using the eLibrary link. Click on
the eLibrary link, click on ``General Search'' and enter the docket
number excluding the last three digits in the Docket Number field
(i.e., CP10-493). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-29837 Filed 11-26-10; 8:45 am]
BILLING CODE 6717-01-P