Use of Additional Portable Oxygen Concentrator Devices on Board Aircraft, 739-742 [E9-31380]
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Rules and Regulations
Federal Register
Vol. 75, No. 3
Wednesday, January 6, 2010
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 121
[Docket No. FAA–2009–0767; SFAR 106]
RIN 2120–AJ55
Use of Additional Portable Oxygen
Concentrator Devices on Board
Aircraft
AGENCY: Federal Aviation
Administration (FAA), DOT.
ACTION:
Final rule.
SUMMARY: This action amends Special
Federal Aviation Regulation 106 (SFAR
106), Use of Certain Portable Oxygen
Concentrator Devices on Board Aircraft,
to allow for the use of four additional
portable oxygen concentrator (POC)
devices on board aircraft, provided
certain conditions in the SFAR are met.
This action is necessary to allow all
POC devices deemed acceptable by the
FAA to be available to the traveling
public in need of oxygen therapy, for
use in air commerce. When this rule
becomes effective, there will be a total
of 11 different POC devices the FAA
finds acceptable for use on board
aircraft, and passengers will be able to
carry these devices on board the aircraft
and use them with the approval of the
aircraft operator.
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DATES: This final rule amending SFAR
106 will become effective on January 6,
2010.
FOR FURTHER INFORMATION CONTACT:
David Catey, Air Transportation
Division, Flight Standards Service,
Federal Aviation Administration, 800
Independence Avenue, SW.,
Washington, DC 20591. Telephone:
(202) 267–8166.
SUPPLEMENTARY INFORMATION:
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Authority for This Rulemaking
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States Code (49
U.S.C.). Subtitle I, Section 106 describes
the authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority.
The FAA is authorized to issue this
final rule pursuant to 49 U.S.C. Section
44701. Under that section, the FAA is
authorized to establish regulations and
minimum standards for other practices,
methods, and procedures the
Administrator finds necessary for air
commerce and national security.
Background
On July 12, 2005, the FAA published
Special Federal Aviation Regulation 106
(SFAR 106) entitled, ‘‘Use of Certain
Portable Oxygen Concentrator Devices
on Board Aircraft’’ (70 FR 40156). SFAR
106 is the result of a notice the FAA
published in July 2004 (69 FR 42324) to
address the needs of passengers who
must travel with medical oxygen. Prior
to publication of SFAR 106, passengers
in need of medical oxygen during air
transportation faced many obstacles
when requesting service. Many aircraft
operators did not provide medical
oxygen service aboard flights, and those
that did often provided service at a price
that travelers could not afford.
Coordinating service between operators
and suppliers at airports was also
difficult, and passengers frequently
chose not to fly because of these
difficulties.
New medical oxygen technologies
approved by the Food and Drug
Administration (FDA) reduce the risks
typically associated with compressed
oxygen and provide a safe alternative for
passengers who need oxygen therapy.
Several manufacturers have developed
small portable oxygen concentrators
(POC) that work by separating oxygen
from nitrogen and other gases contained
in ambient air and dispensing it in
concentrated form to the user with an
oxygen concentration of about 90%. The
POCs operate using either rechargeable
batteries or, if the aircraft operator
obtains approval from the FAA, aircraft
electrical power.
In addition, the Pipeline and
Hazardous Materials Safety
Administration (PHMSA) has
determined that the POCs covered by
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this amendment are not hazardous
materials. Thus, they do not require the
same level of special handling as
compressed oxygen, and are safe for use
on board aircraft, provided certain
conditions for their use are met.
SFAR 106 permits passengers to carry
on and use certain POCs on board
aircraft if the aircraft operator ensures
that the conditions specified in the
SFAR for their use are met. The devices
initially determined acceptable for use
in SFAR 106, published July 12, 2005,
were the AirSep Corporation’s LifeStyle
and the Inogen, Inc.’s Inogen One POCs.
SFAR 106 was amended on September
12, 2006, (71 FR 53954) to add three
additional POC devices, AirSep
Corporation’s FreeStyle, SeQual
Technologies’ Eclipse, and Repironics
Inc.’s EverGo, to the original SFAR.
SFAR 106 was amended again on
January 15, 2009, (74 FR 2351) in a
similar manner to add two more POC
devices, Delphi Medical Systems’ RS–
00400 and Invacare Corporation’s
XPO2, to the original SFAR. This final
rule adds four additional POC devices,
DeVilbiss Healthcare Inc.’s iGo,
International Biophysics Corporation’s
LifeChoice, Inogen Inc.’s Inogen One G2,
and Oxlife LLC.’s Oxlife Independence
Oxygen Concentrator, that may be
carried on and used by a passenger on
board an aircraft.
Aircraft operators can now offer
medical oxygen service as they did
before SFAR 106 was enacted, or they
can meet certain conditions and allow
passengers to carry on and use one of
the POC devices covered in SFAR 106.
SFAR 106 is an enabling rule, which
means that no aircraft operator is
required to allow passengers to operate
these POC devices on board its aircraft,
but it may allow them to be operated on
board. If one of these devices is allowed
by the aircraft operator to be carried on
board, the conditions in the SFAR must
be met.
When SFAR 106 was published, the
FAA committed to establishing a single
standard for all POCs so that regulations
wouldn’t apply to specific
manufacturers and models of device.
Whenever possible, the FAA tries to
regulate by creating performance-based
standards rather than approving by
manufacturer. In the case of SFAR 106,
the quickest and easiest way to serve
both the passenger and the aircraft
operator was to allow the use of the
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Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations
devices determined to be acceptable by
the FAA in SFAR 106 in a special,
temporary regulation. As we stated in
the preamble discussion of the final rule
that established SFAR 106, ‘‘while we
are committed to developing a
performance-based standard for all
future POC devices, we do not want to
prematurely develop standards that
have the effect of stifling new
technology of which we are unaware.’’
We developed and published SFAR 106
so that passengers who otherwise could
not fly could do so with an affordable
alternative to what existed before SFAR
106 was published.
We continue to pursue the
performance-based standard for all
POCs. This process is time-consuming
and we intend to publish a notice in the
Federal Register and offer the public a
chance to comment on the proposal
when it is complete. In the meantime,
manufacturers continue to create new
and better POCs, and several have
requested that their product also be
included as an acceptable device in
SFAR 106. These manufacturers include
DeVilbiss Healthcare Inc., International
Biophysics Corporation, Inogen Inc.,
and Oxlife LLC. Each of these
companies has formally petitioned the
FAA for inclusion in SFAR 106 by
submitting documentation of the
devices to the Department of
Transportation’s Docket Management
System. That documentation is available
at https://www.regulations.gov under the
following docket numbers:
1. DeVilbiss Healthcare Inc.—FAA–
2008–0963;
2. International Biophysics
Corporation—FAA–2009–0087;
3. Inogen Inc.—FAA–2009–0620; and
4. Oxlife LLC—FAA–2009–0065.
As stated in Section 2 of SFAR 106,
no covered device may contain
hazardous materials as determined by
PHMSA (written documentation
necessary), and each device must also
be regulated by the FDA. Each petitioner
included technical specifications for the
devices in their request for approval,
along with the required documentation
from PHMSA and the FDA. The
petitioners provided the FAA with the
required documentation for the
following POC devices:
1. DeVilbiss Healthcare Inc.’s iGo;
2. International Biophysics
Corporation’s LifeChoice;
3. Inogen Inc.’s Inogen One G2; and
4. Oxlife LLC.’s Oxlife Independence
Oxygen Concentrator.
The Rule
This amendment to SFAR 106 will
include the DeVilbiss Healthcare Inc.’s
iGo, International Biophysics
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Corporation’s LifeChoice, Inogen Inc.’s
Inogen One G2, and Oxlife LLC.’s Oxlife
Independence Oxygen Concentrator
devices in the list of POC devices
authorized for use in air commerce. The
FAA has reviewed each individual
device and accepted the documentation
provided by the manufacturers. That
documentation includes letters
provided to the manufacturer by
PHMSA and the FDA affirming the
status of each device as it pertains to the
requisites stated in SFAR 106.
After reviewing the applicable FDA
safety standards and the PHMSA
findings, these devices were determined
by the FAA to be acceptable for use in
air commerce.
Good Cause for Adoption of This Final
Rule Without Notice and Comment
As stated above, SFAR 106 was
published on July 12, 2005. We stated
in the preamble of that final rule that
the AirSep LifeStyle and Inogen One
POC devices were the only known
acceptable devices when the rule was
published. We also stated in that final
rule that ‘‘we cannot predict how future
products may be developed and work.’’
We initiated a notice and comment
period for the use of POC devices on
board aircraft on July 14, 2004, (69 FR
42324) and responded to the comments
received in response to that NPRM in
the final rule published in 2005.
Therefore, it is unnecessary to publish
a notice to request comments on this
amendment because all issues related to
the use of POC devices on board an
aircraft have already been discussed.
Further notice and comment would also
delay the acceptance of the DeVilbiss
Healthcare Inc.’s iGo, International
Biophysics Corporation’s LifeChoice,
Inogen Inc.’s Inogen One G2, and Oxlife
LLC.’s Oxlife Independence Oxygen
Concentrator POC devices as authorized
for use on board aircraft, which would
delay their availability for passengers in
need of oxygen therapy.
Therefore, I find that notice and
public comment under 5 U.S.C. 553(b)
is unnecessary and contrary to the
public interest. Further, I find that good
cause exists for making this rule
effective immediately upon publication.
International Compatibility
In keeping with U.S. obligations
under the Convention on International
Civil Aviation, it is FAA policy to
comply with International Civil
Aviation Organization (ICAO) Standards
and Recommended Practices to the
maximum extent practicable. The FAA
determined that there are no ICAO
Standards and Recommended Practices
that correspond to these regulations. I
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find that this action is fully consistent
with my obligations under 49 U.S.C.
40105(b)(1)(A) to ensure that I exercise
my duties consistently with the
obligations of the United States under
international agreements.
Paperwork Reduction Act
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)), the FAA submitted a copy of
the new information collection
requirements in SFAR 106 to the Office
of Management and Budget for its
review. OMB approved the collection of
this information and assigned OMB
Control Number 2120–0702.
This final rule requires that if a
passenger carries a POC device on board
the aircraft with the intent to use it
during the flight, he or she must inform
the pilot in command of that flight.
Additionally, the passenger who plans
to use the device must provide a written
statement signed by a licensed
physician that verifies the passenger’s
ability to operate the device, respond to
any alarms, the extent to which the
passenger must use the POC (all or a
portion of the flight), and prescribes the
maximum oxygen flow rate.
Please note that an agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
The Paperwork Reduction Act
paragraph in the final rule that
established SFAR 106 still applies to
this amendment. The availability of four
new POC devices will likely increase
the availability and options for a
passenger in need of oxygen therapy,
but the paperwork burden discussed in
the original final rule is unchanged.
Therefore, the OMB Control Number
associated with this collection remains
2120–0702.
Regulatory Evaluation, Regulatory
Flexibility Determination, International
Trade Impact Assessment, and
Unfunded Mandates Assessment
Changes to Federal regulations must
undergo several economic analyses.
First, Executive Order 12866 directs that
each Federal agency shall propose or
adopt a regulation only upon a reasoned
determination that the benefits of the
intended regulation justify its costs.
Second, the Regulatory Flexibility Act
of 1980 (Pub. L. 96–354) requires
agencies to analyze the economic
impact of regulatory changes on small
entities. Third, the Trade Agreements
Act (Pub. L. 96–39) prohibits agencies
from setting standards that create
unnecessary obstacles to the foreign
commerce of the United States. In
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developing U.S. standards, this Trade
Act requires agencies to consider
international standards and, where
appropriate, that they be the basis of
U.S. standards. Fourth, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4) requires agencies to prepare a
written assessment of the costs, benefits,
and other effects of proposed or final
rules that include a Federal mandate
likely to result in the expenditure by
State, local, or Tribal governments, in
the aggregate, or by the private sector, of
$100 million or more annually (adjusted
for inflation with base year of 1995).
This portion of the preamble
summarizes the FAA’s analysis of the
economic impacts of this final rule.
Department of Transportation Order
DOT 2100.5 prescribes policies and
procedures for simplification, analysis,
and review of regulations. If the
expected cost impact is so minimal that
a proposed or final rule does not
warrant a full evaluation, this order
permits that a statement to that effect
and the basis for it be included in the
preamble if a full regulatory evaluation
of the cost and benefits is not prepared.
Such a determination has been made for
this final rule. The reasoning for this
determination follows:
This action amends Special Federal
Aviation Regulation 106 (SFAR 106),
Use of Certain Portable Oxygen
Concentrator Devices On Board Aircraft,
to allow for the use of the DeVilbiss
Healthcare Inc.’s iGo, International
Biophysics Corporation’s LifeChoice,
Inogen Inc.’s Inogen One G2, and Oxlife
LLC.’s Oxlife Independence Oxygen
Concentrator portable oxygen
concentrator (POC) devices on board
aircraft, provided certain conditions in
the SFAR are met. This action is
necessary to allow additional POC
devices deemed acceptable by the FAA
to be available to the traveling public in
need of oxygen therapy, for use in air
commerce. When this rule becomes
effective, there will be a total of eleven
different POC devices the FAA finds
acceptable for use on board aircraft, and
passengers will be able to carry these
devices on board the aircraft and use
them with the approval of the aircraft
operator.
FAA has, therefore, determined that
this final rule is not a ‘‘significant
regulatory action’’ as defined in section
3(f) of Executive Order 12866, and is not
‘‘significant’’ as defined in DOT’s
Regulatory Policies and Procedures.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980
(Pub. L. 96–354) (RFA) establishes ‘‘as a
principle of regulatory issuance that
agencies shall endeavor, consistent with
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the objectives of the rule and of
applicable statutes, to fit regulatory and
informational requirements to the scale
of the businesses, organizations, and
governmental jurisdictions subject to
regulation. To achieve this principle,
agencies are required to solicit and
consider flexible regulatory proposals
and to explain the rationale for their
actions to assure that such proposals are
given serious consideration.’’ The RFA
covers a wide-range of small entities,
including small businesses, not-forprofit organizations, and small
governmental jurisdictions.
Agencies must perform a review to
determine whether a rule will have a
significant economic impact on a
substantial number of small entities. If
the agency determines that it will, the
agency must prepare a regulatory
flexibility analysis as described in the
RFA.
However, if an agency determines that
a rule is not expected to have a
significant economic impact on a
substantial number of small entities,
section 605(b) of the RFA provides that
the head of the agency may so certify
and a regulatory flexibility analysis is
not required. The certification must
include a statement providing the
factual basis for this determination, and
the reasoning should be clear.
This final rule adds DeVilbiss
Healthcare Inc.’s iGo, International
Biophysics Corporation’s LifeChoice,
Inogen Inc.’s Inogen One G2, and Oxlife
LLC.’s Oxlife Independence Oxygen
Concentrator to the list of authorized
POC devices in SFAR 106. Its economic
impact is minimal. Therefore, as the
FAA Administrator, I certify that this
action will not have a significant
economic impact on a substantial
number of small entities.
International Trade Analysis
The Trade Agreements Act of 1979
(Pub. L. 96–39), as amended by the
Uruguay Round Agreements Act (Pub.
L. 103–465), prohibits Federal agencies
from establishing any standards or
engaging in related activities that create
unnecessary obstacles to the foreign
commerce of the United States.
Pursuant to these Acts, the
establishment of standards are not
considered unnecessary obstacles to the
foreign commerce of the United States,
so long as the standards have a
legitimate domestic objective, such the
protection of safety, and do not operate
in a manner that excludes imports that
meet this objective. The statute also
requires consideration of international
standards and, where appropriate, that
they be the basis for U.S. standards. The
FAA notes the purpose is to ensure the
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741
safety of the American public, and has
assessed the effects of this rule to ensure
it does not exclude imports that meet
this objective. As a result, this final rule
is not considered as creating an
unnecessary obstacle to foreign
commerce.
Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4)
requires each Federal agency to prepare
a written statement assessing the effects
of any Federal mandate in a proposed or
final agency rule that may result in an
expenditure of $100 million or more (in
1995 dollars) in any one year by State,
local, and Tribal governments, in the
aggregate, or by the private sector; such
a mandate is deemed to be a ‘‘significant
regulatory action.’’ The FAA currently
uses an inflation-adjusted value of
$136.1 million in lieu of $100 million.
This final rule does not contain such
a mandate; therefore, the requirements
of Title II of the Act do not apply.
Executive Order 13132, Federalism
The FAA has analyzed this final rule
under the principles and criteria of
Executive Order 13132, Federalism. We
determined that this action will not
have a substantial direct effect on the
States, or the relationship between the
national Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Therefore, we
have determined that this final rule does
not have federalism implications.
Plain Language
In response to the June 1, 1998,
Presidential Memorandum regarding the
use of plain language, the FAA reexamined the writing style currently
used in the development of regulations.
The memorandum requires Federal
agencies to communicate clearly with
the public. We are interested in your
comments on whether the style of this
document is clear, and in any other
suggestions you might have to improve
the clarity of FAA communications that
affect you. You can get more
information about the Presidential
memorandum and the plain
language initiative at
https://www.plainlanguage.gov.
Environmental Analysis
FAA Order 1050.1E identifies FAA
actions that are categorically excluded
from preparation of an environmental
assessment or environmental impact
statement under the National
Environmental Policy Act in the
absence of extraordinary circumstances.
The FAA has determined this
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Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations
rulemaking action qualifies for the
categorical exclusion identified in
paragraph 312f and involves no
extraordinary circumstances.
Title 14, Code of Federal Regulations, as
follows:
PART 121—OPERATING
REQUIREMENTS: DOMESTIC, FLAG,
AND SUPPLEMENTAL OPERATIONS
Regulations That Significantly Affect
Energy Supply, Distribution, or Use
The FAA analyzed this final rule
under Executive Order 13211, Actions
Concerning Regulations that
Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We
have determined that it is not a
‘‘significant energy action’’ under the
executive order because it is not a
‘‘significant regulatory action’’ and it is
not likely to have a significant adverse
effect on the supply, distribution, or use
of energy.
Availability of Rulemaking Documents
You can get an electronic copy using
the Internet by:
(1) Searching the Federal
eRulemaking Portal at https://
www.regulations.gov;
(2) Visiting the FAA’s Regulations and
Policies Web page at https://
www.faa.gov/regulations_policies/; or
(3) Accessing the Government
Printing Office’s Web page at https://
www.gpoaccess.gov/fr/.
You can also get a copy by sending a
request to the Federal Aviation
Administration, Office of Rulemaking,
ARM–1, 800 Independence Avenue,
SW., Washington, DC 20591, or by
calling (202) 267–9680. Make sure to
identify the amendment number or
docket number of this rulemaking.
Small Business Regulatory Enforcement
Fairness Act
The Small Business Regulatory
Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with
small entity requests for information or
advice about compliance with statutes
and regulations within its jurisdiction.
Therefore, any small entity that has a
question regarding this document may
contact their local FAA official, or the
person listed under FOR FURTHER
INFORMATION CONTACT. You can find out
more about SBREFA on the Internet at
our site, https://www.faa.gov/
regulations_policies/rulemaking/
sbre_act/.
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List of Subjects in 14 CFR Part 121
Air carriers, Aircraft, Airmen, Alcohol
abuse, Drug abuse, Reporting and
recordkeeping requirements.
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends SFAR No. 106 to Chapter II of
■
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14:05 Jan 05, 2010
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1. The authority citation for part 121
continues to read as follows:
Issued in Washington, DC, on December
22, 2009.
J. Randolph Babbitt,
Administrator.
[FR Doc. E9–31380 Filed 1–5–10; 8:45 am]
BILLING CODE 4910–13–P
■
Authority: 49 U.S.C. 106(g), 1153, 40101,
40102, 40103, 40113, 41721, 44105, 44106,
44111, 44701–44717, 44722, 44901, 44903,
44904, 44906, 44912, 44914, 44936, 44938,
46103, 46105.
2. Amend SFAR 106 by revising
sections 2 and 3(a) introductory text to
read as follows:
■
Special Federal Aviation Regulation
106—Rules for Use of Portable Oxygen
Concentrator Systems on Board
Aircraft
*
*
*
*
*
Section 2. Definitions—For the
purposes of this SFAR the following
definitions apply: Portable Oxygen
Concentrator: means the AirSep
FreeStyle, AirSep LifeStyle, Delphi RS–
00400, DeVilbiss Healthcare iGo, Inogen
One, Inogen One G2, International
Biophysics LifeChoice, Invacare
XPO100, Oxlife Independence Oxygen
Concentrator, Respironics EverGo, and
SeQual Eclipse Portable Oxygen
Concentrator medical device units as
long as those medical device units: (1)
Do not contain hazardous materials as
determined by the Pipeline and
Hazardous Materials Safety
Administration; (2) are also regulated by
the Food and Drug Administration; and
(3) assist a user of medical oxygen under
a doctor’s care. These units perform by
separating oxygen from nitrogen and
other gases contained in ambient air and
dispensing it in concentrated form to
the user.
Section 3. Operating Requirements—
(a) No person may use and no aircraft
operator may allow the use of any
portable oxygen concentrator device,
except the AirSep FreeStyle, AirSep
LifeStyle, Delphi RS–00400, DeVilbiss
Healthcare iGo, Inogen One, Inogen One
G2, International Biophysics LifeChoice,
Invacare XPO100, Oxlife Independence
Oxygen Concentrator, Respironics
EverGo, and SeQual Eclipse Portable
Oxygen Concentrator units. These units
may be carried on and used by a
passenger on board an aircraft provided
the aircraft operator ensures that the
following conditions are satisfied:
*
*
*
*
*
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SECURITIES AND EXCHANGE
COMMISSION
17 CFR Part 275
[Release No. IA–2965A; File No. S7–23–07]
RIN 3235–AJ96
Temporary Rule Regarding Principal
Trades With Certain Advisory Clients
AGENCY: Securities and Exchange
Commission.
ACTION: Final rule; correction.
SUMMARY: On December 30, 2009, the
Securities and Exchange Commission
published a Federal Register document
adopting as final Rule 206(3)–3T under
the Investment Advisers Act of 1940,
the interim final temporary rule that
establishes an alternative means for
investment advisers who are registered
with the Commission as broker-dealers
to meet the requirements of Section
206(3) of the Investment Advisers Act
when they act in a principal capacity in
transactions with certain of their
advisory clients. As adopted, the only
change to the rule was the expiration
date in paragraph (d) of the section.
Rule 206(3)–3T will sunset on December
31, 2010. This document makes a
correction to that document.
DATES: Effective December 31, 2009. The
DATES section for FR Doc. 2009–30877,
published on December 30, 2009 (74 FR
69009) is corrected to read ‘‘DATES: The
amendments in this document are
effective December 30, 2009 and the
expiration date for 17 CFR 275.206(3)–
3T is extended to December 31, 2010’’.
FOR FURTHER INFORMATION CONTACT:
Sarah A. Bessin, Assistant Director,
Daniel S. Kahl, Branch Chief, or
Matthew N. Goldin, Senior Counsel, at
(202) 551–6787 or IArules@sec.gov,
Office of Investment Adviser
Regulation, Division of Investment
Management, Securities and Exchange
Commission, 100 F Street, NE.,
Washington, DC 20549–5041.
SUPPLEMENTARY INFORMATION: The
Securities and Exchange Commission is
correcting the DATES section for FR Doc.
2009–30877, published on December 30,
2009 (74 FR 69009), to read ‘‘DATES: The
amendments in this document are
effective December 20, 2009 and the
expiration date for 17 CFR 275.206(3)–
3T is extended to December 31, 2010.’’
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Agencies
[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Rules and Regulations]
[Pages 739-742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-31380]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 /
Rules and Regulations
[[Page 739]]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 121
[Docket No. FAA-2009-0767; SFAR 106]
RIN 2120-AJ55
Use of Additional Portable Oxygen Concentrator Devices on Board
Aircraft
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
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SUMMARY: This action amends Special Federal Aviation Regulation 106
(SFAR 106), Use of Certain Portable Oxygen Concentrator Devices on
Board Aircraft, to allow for the use of four additional portable oxygen
concentrator (POC) devices on board aircraft, provided certain
conditions in the SFAR are met. This action is necessary to allow all
POC devices deemed acceptable by the FAA to be available to the
traveling public in need of oxygen therapy, for use in air commerce.
When this rule becomes effective, there will be a total of 11 different
POC devices the FAA finds acceptable for use on board aircraft, and
passengers will be able to carry these devices on board the aircraft
and use them with the approval of the aircraft operator.
DATES: This final rule amending SFAR 106 will become effective on
January 6, 2010.
FOR FURTHER INFORMATION CONTACT: David Catey, Air Transportation
Division, Flight Standards Service, Federal Aviation Administration,
800 Independence Avenue, SW., Washington, DC 20591. Telephone: (202)
267-8166.
SUPPLEMENTARY INFORMATION:
Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code (49 U.S.C.). Subtitle I,
Section 106 describes the authority of the FAA Administrator. Subtitle
VII, Aviation Programs, describes in more detail the scope of the
agency's authority.
The FAA is authorized to issue this final rule pursuant to 49
U.S.C. Section 44701. Under that section, the FAA is authorized to
establish regulations and minimum standards for other practices,
methods, and procedures the Administrator finds necessary for air
commerce and national security.
Background
On July 12, 2005, the FAA published Special Federal Aviation
Regulation 106 (SFAR 106) entitled, ``Use of Certain Portable Oxygen
Concentrator Devices on Board Aircraft'' (70 FR 40156). SFAR 106 is the
result of a notice the FAA published in July 2004 (69 FR 42324) to
address the needs of passengers who must travel with medical oxygen.
Prior to publication of SFAR 106, passengers in need of medical oxygen
during air transportation faced many obstacles when requesting service.
Many aircraft operators did not provide medical oxygen service aboard
flights, and those that did often provided service at a price that
travelers could not afford. Coordinating service between operators and
suppliers at airports was also difficult, and passengers frequently
chose not to fly because of these difficulties.
New medical oxygen technologies approved by the Food and Drug
Administration (FDA) reduce the risks typically associated with
compressed oxygen and provide a safe alternative for passengers who
need oxygen therapy. Several manufacturers have developed small
portable oxygen concentrators (POC) that work by separating oxygen from
nitrogen and other gases contained in ambient air and dispensing it in
concentrated form to the user with an oxygen concentration of about
90%. The POCs operate using either rechargeable batteries or, if the
aircraft operator obtains approval from the FAA, aircraft electrical
power.
In addition, the Pipeline and Hazardous Materials Safety
Administration (PHMSA) has determined that the POCs covered by this
amendment are not hazardous materials. Thus, they do not require the
same level of special handling as compressed oxygen, and are safe for
use on board aircraft, provided certain conditions for their use are
met.
SFAR 106 permits passengers to carry on and use certain POCs on
board aircraft if the aircraft operator ensures that the conditions
specified in the SFAR for their use are met. The devices initially
determined acceptable for use in SFAR 106, published July 12, 2005,
were the AirSep Corporation's LifeStyle and the Inogen, Inc.'s Inogen
One POCs. SFAR 106 was amended on September 12, 2006, (71 FR 53954) to
add three additional POC devices, AirSep Corporation's FreeStyle,
SeQual Technologies' Eclipse, and Repironics Inc.'s EverGo, to the
original SFAR. SFAR 106 was amended again on January 15, 2009, (74 FR
2351) in a similar manner to add two more POC devices, Delphi Medical
Systems' RS-00400 and Invacare Corporation's XPO2, to the original
SFAR. This final rule adds four additional POC devices, DeVilbiss
Healthcare Inc.'s iGo, International Biophysics Corporation's
LifeChoice, Inogen Inc.'s Inogen One G2, and Oxlife LLC.'s Oxlife
Independence Oxygen Concentrator, that may be carried on and used by a
passenger on board an aircraft.
Aircraft operators can now offer medical oxygen service as they did
before SFAR 106 was enacted, or they can meet certain conditions and
allow passengers to carry on and use one of the POC devices covered in
SFAR 106. SFAR 106 is an enabling rule, which means that no aircraft
operator is required to allow passengers to operate these POC devices
on board its aircraft, but it may allow them to be operated on board.
If one of these devices is allowed by the aircraft operator to be
carried on board, the conditions in the SFAR must be met.
When SFAR 106 was published, the FAA committed to establishing a
single standard for all POCs so that regulations wouldn't apply to
specific manufacturers and models of device. Whenever possible, the FAA
tries to regulate by creating performance-based standards rather than
approving by manufacturer. In the case of SFAR 106, the quickest and
easiest way to serve both the passenger and the aircraft operator was
to allow the use of the
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devices determined to be acceptable by the FAA in SFAR 106 in a
special, temporary regulation. As we stated in the preamble discussion
of the final rule that established SFAR 106, ``while we are committed
to developing a performance-based standard for all future POC devices,
we do not want to prematurely develop standards that have the effect of
stifling new technology of which we are unaware.'' We developed and
published SFAR 106 so that passengers who otherwise could not fly could
do so with an affordable alternative to what existed before SFAR 106
was published.
We continue to pursue the performance-based standard for all POCs.
This process is time-consuming and we intend to publish a notice in the
Federal Register and offer the public a chance to comment on the
proposal when it is complete. In the meantime, manufacturers continue
to create new and better POCs, and several have requested that their
product also be included as an acceptable device in SFAR 106. These
manufacturers include DeVilbiss Healthcare Inc., International
Biophysics Corporation, Inogen Inc., and Oxlife LLC. Each of these
companies has formally petitioned the FAA for inclusion in SFAR 106 by
submitting documentation of the devices to the Department of
Transportation's Docket Management System. That documentation is
available at https://www.regulations.gov under the following docket
numbers:
1. DeVilbiss Healthcare Inc.--FAA-2008-0963;
2. International Biophysics Corporation--FAA-2009-0087;
3. Inogen Inc.--FAA-2009-0620; and
4. Oxlife LLC--FAA-2009-0065.
As stated in Section 2 of SFAR 106, no covered device may contain
hazardous materials as determined by PHMSA (written documentation
necessary), and each device must also be regulated by the FDA. Each
petitioner included technical specifications for the devices in their
request for approval, along with the required documentation from PHMSA
and the FDA. The petitioners provided the FAA with the required
documentation for the following POC devices:
1. DeVilbiss Healthcare Inc.'s iGo;
2. International Biophysics Corporation's LifeChoice;
3. Inogen Inc.'s Inogen One G2; and
4. Oxlife LLC.'s Oxlife Independence Oxygen Concentrator.
The Rule
This amendment to SFAR 106 will include the DeVilbiss Healthcare
Inc.'s iGo, International Biophysics Corporation's LifeChoice, Inogen
Inc.'s Inogen One G2, and Oxlife LLC.'s Oxlife Independence Oxygen
Concentrator devices in the list of POC devices authorized for use in
air commerce. The FAA has reviewed each individual device and accepted
the documentation provided by the manufacturers. That documentation
includes letters provided to the manufacturer by PHMSA and the FDA
affirming the status of each device as it pertains to the requisites
stated in SFAR 106.
After reviewing the applicable FDA safety standards and the PHMSA
findings, these devices were determined by the FAA to be acceptable for
use in air commerce.
Good Cause for Adoption of This Final Rule Without Notice and Comment
As stated above, SFAR 106 was published on July 12, 2005. We stated
in the preamble of that final rule that the AirSep LifeStyle and Inogen
One POC devices were the only known acceptable devices when the rule
was published. We also stated in that final rule that ``we cannot
predict how future products may be developed and work.'' We initiated a
notice and comment period for the use of POC devices on board aircraft
on July 14, 2004, (69 FR 42324) and responded to the comments received
in response to that NPRM in the final rule published in 2005.
Therefore, it is unnecessary to publish a notice to request comments on
this amendment because all issues related to the use of POC devices on
board an aircraft have already been discussed. Further notice and
comment would also delay the acceptance of the DeVilbiss Healthcare
Inc.'s iGo, International Biophysics Corporation's LifeChoice, Inogen
Inc.'s Inogen One G2, and Oxlife LLC.'s Oxlife Independence Oxygen
Concentrator POC devices as authorized for use on board aircraft, which
would delay their availability for passengers in need of oxygen
therapy.
Therefore, I find that notice and public comment under 5 U.S.C.
553(b) is unnecessary and contrary to the public interest. Further, I
find that good cause exists for making this rule effective immediately
upon publication.
International Compatibility
In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations. I find that this action is fully
consistent with my obligations under 49 U.S.C. 40105(b)(1)(A) to ensure
that I exercise my duties consistently with the obligations of the
United States under international agreements.
Paperwork Reduction Act
As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the FAA submitted a copy of the new information collection
requirements in SFAR 106 to the Office of Management and Budget for its
review. OMB approved the collection of this information and assigned
OMB Control Number 2120-0702.
This final rule requires that if a passenger carries a POC device
on board the aircraft with the intent to use it during the flight, he
or she must inform the pilot in command of that flight. Additionally,
the passenger who plans to use the device must provide a written
statement signed by a licensed physician that verifies the passenger's
ability to operate the device, respond to any alarms, the extent to
which the passenger must use the POC (all or a portion of the flight),
and prescribes the maximum oxygen flow rate.
Please note that an agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The Paperwork Reduction
Act paragraph in the final rule that established SFAR 106 still applies
to this amendment. The availability of four new POC devices will likely
increase the availability and options for a passenger in need of oxygen
therapy, but the paperwork burden discussed in the original final rule
is unchanged. Therefore, the OMB Control Number associated with this
collection remains 2120-0702.
Regulatory Evaluation, Regulatory Flexibility Determination,
International Trade Impact Assessment, and Unfunded Mandates Assessment
Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In
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developing U.S. standards, this Trade Act requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) requires agencies to prepare a written assessment of
the costs, benefits, and other effects of proposed or final rules that
include a Federal mandate likely to result in the expenditure by State,
local, or Tribal governments, in the aggregate, or by the private
sector, of $100 million or more annually (adjusted for inflation with
base year of 1995). This portion of the preamble summarizes the FAA's
analysis of the economic impacts of this final rule.
Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows:
This action amends Special Federal Aviation Regulation 106 (SFAR
106), Use of Certain Portable Oxygen Concentrator Devices On Board
Aircraft, to allow for the use of the DeVilbiss Healthcare Inc.'s iGo,
International Biophysics Corporation's LifeChoice, Inogen Inc.'s Inogen
One G2, and Oxlife LLC.'s Oxlife Independence Oxygen Concentrator
portable oxygen concentrator (POC) devices on board aircraft, provided
certain conditions in the SFAR are met. This action is necessary to
allow additional POC devices deemed acceptable by the FAA to be
available to the traveling public in need of oxygen therapy, for use in
air commerce. When this rule becomes effective, there will be a total
of eleven different POC devices the FAA finds acceptable for use on
board aircraft, and passengers will be able to carry these devices on
board the aircraft and use them with the approval of the aircraft
operator.
FAA has, therefore, determined that this final rule is not a
``significant regulatory action'' as defined in section 3(f) of
Executive Order 12866, and is not ``significant'' as defined in DOT's
Regulatory Policies and Procedures.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
This final rule adds DeVilbiss Healthcare Inc.'s iGo, International
Biophysics Corporation's LifeChoice, Inogen Inc.'s Inogen One G2, and
Oxlife LLC.'s Oxlife Independence Oxygen Concentrator to the list of
authorized POC devices in SFAR 106. Its economic impact is minimal.
Therefore, as the FAA Administrator, I certify that this action will
not have a significant economic impact on a substantial number of small
entities.
International Trade Analysis
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing any standards or engaging in related
activities that create unnecessary obstacles to the foreign commerce of
the United States. Pursuant to these Acts, the establishment of
standards are not considered unnecessary obstacles to the foreign
commerce of the United States, so long as the standards have a
legitimate domestic objective, such the protection of safety, and do
not operate in a manner that excludes imports that meet this objective.
The statute also requires consideration of international standards and,
where appropriate, that they be the basis for U.S. standards. The FAA
notes the purpose is to ensure the safety of the American public, and
has assessed the effects of this rule to ensure it does not exclude
imports that meet this objective. As a result, this final rule is not
considered as creating an unnecessary obstacle to foreign commerce.
Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and Tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $136.1 million in lieu of $100
million.
This final rule does not contain such a mandate; therefore, the
requirements of Title II of the Act do not apply.
Executive Order 13132, Federalism
The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Therefore, we have determined that this final rule does not
have federalism implications.
Plain Language
In response to the June 1, 1998, Presidential Memorandum regarding
the use of plain language, the FAA re-examined the writing style
currently used in the development of regulations. The memorandum
requires Federal agencies to communicate clearly with the public. We
are interested in your comments on whether the style of this document
is clear, and in any other suggestions you might have to improve the
clarity of FAA communications that affect you. You can get more
information about the Presidential memorandum and the plain language
initiative at https://www.plainlanguage.gov.
Environmental Analysis
FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this
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rulemaking action qualifies for the categorical exclusion identified in
paragraph 312f and involves no extraordinary circumstances.
Regulations That Significantly Affect Energy Supply, Distribution, or
Use
The FAA analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We have determined that it is not
a ``significant energy action'' under the executive order because it is
not a ``significant regulatory action'' and it is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.
Availability of Rulemaking Documents
You can get an electronic copy using the Internet by:
(1) Searching the Federal eRulemaking Portal at https://www.regulations.gov;
(2) Visiting the FAA's Regulations and Policies Web page at https://www.faa.gov/regulations_policies/; or
(3) Accessing the Government Printing Office's Web page at https://www.gpoaccess.gov/fr/.
You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make
sure to identify the amendment number or docket number of this
rulemaking.
Small Business Regulatory Enforcement Fairness Act
The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. Therefore, any small entity that has a question regarding
this document may contact their local FAA official, or the person
listed under FOR FURTHER INFORMATION CONTACT. You can find out more
about SBREFA on the Internet at our site, https://www.faa.gov/regulations_policies/rulemaking/sbre_act/.
List of Subjects in 14 CFR Part 121
Air carriers, Aircraft, Airmen, Alcohol abuse, Drug abuse,
Reporting and recordkeeping requirements.
The Amendment
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In consideration of the foregoing, the Federal Aviation Administration
amends SFAR No. 106 to Chapter II of Title 14, Code of Federal
Regulations, as follows:
PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS
0
1. The authority citation for part 121 continues to read as follows:
Authority: 49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113,
41721, 44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904,
44906, 44912, 44914, 44936, 44938, 46103, 46105.
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2. Amend SFAR 106 by revising sections 2 and 3(a) introductory text to
read as follows:
Special Federal Aviation Regulation 106--Rules for Use of Portable
Oxygen Concentrator Systems on Board Aircraft
* * * * *
Section 2. Definitions--For the purposes of this SFAR the following
definitions apply: Portable Oxygen Concentrator: means the AirSep
FreeStyle, AirSep LifeStyle, Delphi RS-00400, DeVilbiss Healthcare iGo,
Inogen One, Inogen One G2, International Biophysics LifeChoice,
Invacare XPO100, Oxlife Independence Oxygen Concentrator, Respironics
EverGo, and SeQual Eclipse Portable Oxygen Concentrator medical device
units as long as those medical device units: (1) Do not contain
hazardous materials as determined by the Pipeline and Hazardous
Materials Safety Administration; (2) are also regulated by the Food and
Drug Administration; and (3) assist a user of medical oxygen under a
doctor's care. These units perform by separating oxygen from nitrogen
and other gases contained in ambient air and dispensing it in
concentrated form to the user.
Section 3. Operating Requirements--
(a) No person may use and no aircraft operator may allow the use of
any portable oxygen concentrator device, except the AirSep FreeStyle,
AirSep LifeStyle, Delphi RS-00400, DeVilbiss Healthcare iGo, Inogen
One, Inogen One G2, International Biophysics LifeChoice, Invacare
XPO100, Oxlife Independence Oxygen Concentrator, Respironics EverGo,
and SeQual Eclipse Portable Oxygen Concentrator units. These units may
be carried on and used by a passenger on board an aircraft provided the
aircraft operator ensures that the following conditions are satisfied:
* * * * *
Issued in Washington, DC, on December 22, 2009.
J. Randolph Babbitt,
Administrator.
[FR Doc. E9-31380 Filed 1-5-10; 8:45 am]
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