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7892 Federal Register / Vol. 71, No.

31 / Wednesday, February 15, 2006 / Proposed Rules

received. All comments submitted will executing instrument procedures at the The Proposed Amendment
be available for examination in the Middleton Island Airport. In consideration of the foregoing, the
public docket both before and after the The area would be depicted on Federal Aviation Administration
closing date for comments. A report aeronautical charts for pilot reference. proposes to amend 14 CFR part 71 as
summarizing each substantive public The coordinates for this airspace docket follows:
contact with FAA personnel concerned are based on North American Datum 83.
with this rulemaking will be filed in the The Class E airspace areas designated as PART 71—DESIGNATION OF CLASS A,
docket. 700/1200 foot transition areas are CLASS B, CLASS C, CLASS D, AND
Availability of Notice of Proposed published in paragraph 6005 in FAA CLASS E AIRSPACE AREAS;
Rulemakings (NPRMs) Order 7400.9N, Airspace Designations AIRWAYS; ROUTES; AND REPORTING
and Reporting Points, dated September POINTS
An electronic copy of this document 1, 2005, and effective September 15,
may be downloaded through the 1. The authority citation for 14 CFR
2005, which is incorporated by part 71 continues to read as follows:
Internet at http://dms.dot.gov. Recently reference in 14 CFR 71.1. The Class E
published rulemaking documents can airspace designations listed in this Authority: 49 U.S.C. 106(g), 40103, 40113,
also be accessed through the FAA’s Web 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
document would be published 1963 Comp., p. 389.
page at http://www.faa.gov or the subsequently in the Order.
Superintendent of Document’s Web § 71.1 [Amended]
The FAA has determined that this
page at http://www.access.gpo.gov/nara. 2. The incorporation by reference in
proposed regulation only involves an
Additionally, any person may obtain established body of technical 14 CFR 71.1 of Federal Aviation
a copy of this notice by submitting a regulations for which frequent and Administration Order 7400.9N,
request to the Federal Aviation routine amendments are necessary to Airspace Designations and Reporting
Administration, Office of Air Traffic keep them operationally current. It, Points, dated September 1, 2005, and
Airspace Management, ATA–400, 800 therefore—(1) Is not a ‘‘significant effective September 15, 2005, is to be
Independence Avenue, SW., regulatory action’’ under Executive amended as follows:
Washington, DC 20591 or by calling Order 12866; (2) is not a ‘‘significant * * * * *
(202) 267–8783. Communications must rule’’ under DOT Regulatory Policies
identify both docket numbers for this Paragraph 6005 Class E airspace extending
and Procedures (44 FR 11034; February upward from 700 feet or more above the
notice. Persons interested in being 26, 1979); and (3) does not warrant
placed on a mailing list for future surface of the earth.
preparation of a regulatory evaluation as * * * * *
NPRM’s should contact the FAA’s the anticipated impact is so minimal.
Office of Rulemaking, (202) 267–9677, Since this is a routine matter that will AAL AK E5 Middleton Island, AK
to request a copy of Advisory Circular only affect air traffic procedures and air [Revised]
No. 11–2A, Notice of Proposed navigation, it is certified that this rule, Middleton Island Airport, AK
Rulemaking Distribution System, which when promulgated, will not have a (Lat. 59°27′00″ N., long. 146°18′26″ W.)
describes the application procedure. significant economic impact on a Middleton Island VOR/DME
(Lat. 59°25′19″ N., long. 146°21′00″ W.)
The Proposal substantial number of small entities
under the criteria of the Regulatory That airspace extending upward from 700
The FAA is considering an Flexibility Act. feet above the surface within a 6.5-mile
amendment to the Code of Federal radius of the Middleton Island Airport, and
Regulations (14 CFR Part 71), which The FAA’s authority to issue rules within 4 miles either side of the 038° radial
would revise the Class E airspace at regarding aviation safety is found in of the Middleton Island VOR/DME extending
Title 49 of the United States Code. from the 6.5-mile radius to 12 miles northeast
Middleton Island, AK. The intended of the VOR/DME, and that airspace extending
effect of this proposal is to revise Class Subtitle 1, Section 106 describes the
authority of the FAA Administrator. upward from 1,200 feet above the surface
E airspace upward from 700 ft. and within a 42-mile radius of the Middleton
1,200 ft. above the surface to contain Subtitle VII, Aviation Programs, Island VOR/DME.
Instrument Flight Rules (IFR) operations describes in more detail the scope of the
agency’s authority. * * * * *
at Middleton Island, AK.
This rulemaking is promulgated Issued in Anchorage, AK, on February 7,
The FAA Instrument Flight 2006.
Procedures Production and under the authority described in
Subtitle VII, Part A, Subpart 1, Section Anthony M. Wylie,
Maintenance Branch has amended two
40103, Sovereignty and use of airspace. Manager, Safety, Area Flight Service
SIAPs and created two new SIAPs for
Under that section, the FAA is charged Operations.
the Middleton Island Airport. The
with prescribing regulations to ensure [FR Doc. E6–2190 Filed 2–14–06; 8:45 am]
amended approaches are (1) Very High
Frequency Omni-directional Range the safe and efficient use of the BILLING CODE 4910–13–P

(VOR) Runway (RWY) 01, Amendment navigable airspace. This regulation is

(Amdt) 2; and (2) VOR/Distance within the scope of that authority
because it proposes to create Class E DEPARTMENT OF TRANSPORTATION
Measuring Equipment (DME) RWY 19,
Amdt 5. The new approaches are (1) airspace sufficient in size to contain Federal Aviation Administration
Area Navigation (Global Positioning aircraft executing instrument
System) (RNAV (GPS)) RWY 01, procedures at Middleton Island Airport
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14 CFR Parts 121 and 135

Original; and (2) RNAV (GPS) RWY 19, and represents the FAA’s continuing
Original. This action would modify the effort to safely and efficiently use the [Docket No. FAA–2005–22593]
Class E controlled airspace extending navigable airspace.
Mode S Transponder Requirements in
upward from 700 ft. and 1,200 ft. above List of Subjects in 14 CFR Part 71 the National Airspace System
the surface near the Middleton Island
Airport. The proposed airspace is Airspace, Incorporation by reference, AGENCY:Federal Aviation
sufficient in size to contain aircraft Navigation (air). Administration (FAA), DOT.

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Federal Register / Vol. 71, No. 31 / Wednesday, February 15, 2006 / Proposed Rules 7893

Policy notice and disposition of

ACTION: term plan for Mode S transponders, we to install one transponder under the
comments. sought comment on the appropriate date regulations. Any election to install a
for which all current exemptions should second transponder is at FedEx’s
SUMMARY: On October 7, 2005, the terminate. The notice proposed March discretion.
Federal Aviation Administration (FAA) 1, 2007, as the appropriate termination An individual commented that the
published a document in the Federal date. ADS–B system is far superior to Mode
Register announcing its long-term S because it has the capability to receive
policy for Mode S transponder Discussion of Comments other traffic and weather information
equipment requirements. The policy We received comments from AirTran and urged the adoption of a nationwide
also sought comment on the proposed Airways, Inc., Federal Express (FedEx), Capstone policy to benefit all operators
termination date of March 1, 2007, for the Regional Airlines Association (including general aviation) as opposed
operators currently exempted from the (RAA), and one individual. However, to enforcing outdated Mode S
Mode S transponder requirement of 14 while the notice specifically sought equipment. Also, RAA commented it
CFR parts 121 and 135. This action comment on whether March 1, 2007 was would expect the Mode S requirement
responds to the comments and adopts the appropriate date to terminate to be consistent with the FAA’s long
the proposed date for which all current exemptions, no comment term objectives for ADS–B to avoid
applicable exemptions will terminate. responded to that request. Although all costly retrofits.
ADDRESSES: The complete docket for the comments were beyond the scope of the Capstone is a successful initiative, but
proposed exemption policy may be request, we respond to those comments is a limited concept for a defined and
examined at the DOT Docket Web site: below. remote area in southwest Alaska.
http://dms.dot.gov. Interested persons AirTran Airways fully supported that Capstone does not rely on ADS–B
may perform a Simple Search at that all applicable aircraft comply with the technology but rather on Global
Web site, entering the docket number Mode S transponder equipment Positioning Systems (GPS) and Wide
22593. Comments may also be examined requirements. Area Augmentation Systems (WAAS) in
FedEx commented on two aspects of areas where ground sensors are not yet
in Room PL–401, on the Plaza Level of
the notice. First, it questioned whether available. ADS–B is not considered an
the Department of Transportation
it must request an extension of its alternative to the more mature Mode S
Building, 400 Seventh Street, SW.,
current exemption to continue to use technology at this time due to the
Washington, DC between 9 a.m. and 5
the Mode C and Mode A transponders uncertain timeframe of widespread
p.m., except Federal holidays.
installed on its Caravan airplanes until availability of the technology. FAA
FOR FURTHER INFORMATION CONTACT: Ida March 1, 2007. (FedEx’s exemption plans for expanding the ADS–B
Klepper, Office of Rulemaking, Federal expires on March 1, 2006.) Second, technology to the lower 48 states are
Aviation Administration, 800 FedEx stated that it has both Mode A still under review. Lastly, any
Independence Avenue SW., and Mode C transponders installed on requirement to equip and use ADS–B
Washington, DC 20591, telephone (202) its Caravan airplanes. FedEx questioned technology must be established through
267–9677. whether it must replace each rulemaking.
SUPPLEMENTARY INFORMATION transponder with a separate Mode S RAA requested that the agency
Background transponder. complete a cost benefit analysis of the
The FAA does not intend to grant new Mode S policy and provide an
On October 7, 2005, the FAA exemptions or subsequent extensions of opportunity for public comment on that
published two notices in the Federal current exemptions during this interim analysis.
Register concerning the Mode S period unless circumstances warrant. The FAA is required to economically
transponder equipment requirements in FedEx may continue to operate its analyze its intended regulations.1 (A
14 CFR parts 121 and 135. The first Caravan airplanes with Mode A and regulatory evaluation, including cost-
notice withdrew Notice No. 96–5, which Mode C installed, even after expiration benefit analysis, was completed for both
proposed to withdraw the Mode S of its exemption, until the transponders the final rule adopting the Mode S
transponder requirements for part 135 are no longer repairable and must be requirement 2 and the notice proposing
and certain 121 operations. The first replaced. If FedEx finds that the to withdraw the requirement.3) The
October 7 notice summarized our transponders must be replaced after its FAA is not required to conduct an
reassessment of the requirements and exemption terminates, it must do so in economic review because it determines
articulated the basis for our conclusion accordance with the regulations and not to proceed with a proposed
to retain the Mode S transponder install a Mode S transponder. The FAA regulation. A number of exemptions
equipment requirements. (See 70 FR proposed the March 2007 date to were granted between 1996 and 2005.
58966.) Accordingly, the FAA withdrew provide a reasonable time for operators The FAA could have simply denied all
Notice No. 96–5. to plan for the need to replace outdated requests for exemptions until the Mode
The second notice published on equipment when necessary. The FAA S transponder equipment requirement
October 7 announced our policy with did not suggest this date to provide a was in fact rescinded. However, we did
respect to the exemptions granted from vehicle for operators to quickly seek an not view this as supporting the public
the Mode S transponder equipment exemption or extension to bide more interest and concluded that certain
requirements. (See 70 FR 58976.) We time for which to equip their aircraft. exemptions were justified given the
explained that since Notice 96–5 was We do not find that the public interest agency position on Mode S in 1996.
published in May 1996, the agency is served by simply granting additional Several operators have benefited from
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granted several exemptions to the Mode exemptions for yet another year.
S transponder requirements because we It appears to be a business decision by 1 Executive Order 12866, Regulatory Flexibility

were progressing toward the removal of FedEx to have two transponders Act of 1980 (5 U.S.C. 5601, et seq.), Trade
Agreements Act (19 U.S.C. 4 §§ 2531–2533,
this equipment requirement from all installed in its aircraft. This is not a Unfunded Mandate Reform Act of 1995 (Pub. L.
aircraft, except those aircraft operated regulatory requirement. Consequently, if 104–4).
under part 121 and that have TCAS II. FedEx needs to install a Mode S 2 52 FR 3380; February 3, 1987.

As we subsequently revised our long- transponder in its aircraft, it only needs 3 61 FR 26036; May 23, 1996.

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7894 Federal Register / Vol. 71, No. 31 / Wednesday, February 15, 2006 / Proposed Rules

the exemptions and were able to defer Issued in Washington, DC, on February 9, mail. FDA encourages you to continue
the equipage costs for several years. 2006. to submit electronic comments by using
Since that time, technology James J. Ballough, the Federal eRulemaking Portal or the
developments and the availability of Director, Flight Standards Service. agency Web site, as described in the
Mode S avionics dictate that we revise [FR Doc. E6–2178 Filed 2–14–06; 8:45 am] Electronic Submissions portion of this
our policy. As we are retaining the BILLING CODE 4910–13–P paragraph.
Mode S transponder requirements, the Instructions: All submissions received
basis for the current exemptions no must include the agency name and
longer exists. Operators are not entitled DEPARTMENT OF HEALTH AND Docket No(s). and Regulatory
to an exemption as a matter of right. HUMAN SERVICES Information Number (RIN) (if a RIN
Consequently, we do not agree with number has been assigned) for this
RAA’s assertion that the previous grant Food and Drug Administration rulemaking. All comments received may
of exemptions is tantamount to a rule be posted without change to http://
and thus deserving of a cost-benefit 21 CFR Part 892 www.fda.gov/ohrms/dockets/
analysis. We did view, as critical and default.htm, including any personal
[Docket No. 2005N–0467]
warranting public input, the appropriate information provided. For detailed
date for which the exemptions would Medical Devices; Radiology Devices; instructions on submitting comments
terminate and that affected operators Reclassification of Bone Sonometers and additional information on the
would be required to install a Mode S rulemaking process, see the
transponder if their Mode C or Mode A AGENCY: Food and Drug Administration, ‘‘Comments’’ heading of the
transponder could not be repaired and HHS. SUPPLEMENTARY INFORMATION section of
specifically requested comment on that ACTION: Proposed rule. this document.
aspect. Docket: For access to the docket to
SUMMARY: The Food and Drug read background documents or
RAA also stated that there are more
Administration (FDA) is publishing a comments received, go to http://
than 130,000 general aviation users who
proposed rule to reclassify bone www.fda.gov/ohrms/dockets/
are not required to install Mode S and
sonometer devices from class III into default.htm and insert the docket
questioned why the Mode S transponder
class II, subject to special controls. A number(s), found in brackets in the
are required for part 135 operators.
bone sonometer is a device that heading of this document, into the
The Mode S transponder requirement transmits ultrasound energy into the ‘‘Search’’ box and follow the prompts
for part 91 operations was rescinded in human body to measure acoustic and/or go to the Division of Dockets
1992 (57 FR 34614; August 5, 1992). The properties of bone that indicate overall Management, 5630 Fishers Lane, rm.
agency concluded that the expense of bone health and fracture risk. Elsewhere 1061, Rockville, MD 20852.
requiring the equipment for all part 91 in this issue of the Federal Register, FOR FURTHER INFORMATION CONTACT:
operators could not be justified since FDA is announcing the availability of a
the vast majority of general aviation Robert A. Phillips, Center for Devices
draft guidance document entitled ‘‘Class and Radiological Health (HFZ–470),
operators do not operate in congested II Special Controls Guidance Document:
airspace. Furthermore, to impose a Food and Drug Administration, 9200
Bone Sonometers’’ that the agency Corporate Blvd., Rockville, MD 20850,
Mode S requirement on all such proposes to use as a special control for
operators would be unduly burdensome 301–594–1212, ext. 130.
these devices.
with little safety benefit. At this time, SUPPLEMENTARY INFORMATION:
DATES: Submit comments by May 16,
we do not see evidence that this I. Regulatory Authority
rationale is no longer valid.
ADDRESSES: You may submit comments, The Federal Food, Drug, and Cosmetic
As stated previously, any new Act (the act) (21 U.S.C. 301 et seq.), as
exemption or request for extension will identified by Docket No. 2005N–0467,
by any of the following methods: amended by the Medical Device
be evaluated carefully as to whether it Amendments of 1979 (the 1976
would serve the public interest. Electronic Submissions
Submit electronic comments in the amendments) (Public Law 94–295), the
Requesting an exemption simply Safe Medical Devices Act of 1990
following ways:
because previous exemptions have been
• Federal eRulemaking Portal: http:// (SMDA) (Pub. L. 101–629), and the Food
granted is not considered in the public and Drug Administration Modernization
www.regulations.gov. Follow the
interest. Act of 1997 (Public Law 105–115),
instructions for submitting comments.
Adoption of the March 1, 2007 Date • Agency Web site: http:// established a comprehensive system for
www.fda.gov/dockets/ecomments. the regulation of medical devices
The FAA concludes that March 1, Follow the instructions for submitting intended for human use. Section 513 of
2007, provides a reasonable timeframe comments on the agency Web site. the act (21 U.S.C. 360c) established
for the exemptions to terminate. We Written Submissions three categories (classes) of devices,
intend to judiciously exercise our Submit written submissions in the depending on the regulatory controls
authority in reviewing any petitions for following ways: needed to provide reasonable assurance
exemption or requests for extension • FAX: 301–827–6870. of their safety and effectiveness. The
under 14 CFR 11.81. • Mail/Hand delivery/Courier [For three categories of devices are class I
Operators are advised that this policy paper, disk, or CD–ROM submissions]: (general controls), class II (special
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does not require the installation of Division of Dockets Management (HFA– controls), and class III (premarket
Mode S transponders on March 1, 2007. 305), Food and Drug Administration, approval).
Operators may continue to use Mode A 5630 Fishers Lane, rm. 1061, Rockville, Under section 513 of the act, devices
and Mode C transponders beyond the MD 20852. that were in commercial distribution
expiration of their exemption and past To ensure more timely processing of before May 28, 1976 (the date of
March 1, 2007, until they can no longer comments, FDA is no longer accepting enactment of the 1976 amendments),
be repaired and must be replaced. comments submitted to the agency by e- generally referred to as preamendments

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