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32826 Federal Register / Vol. 71, No.

109 / Wednesday, June 7, 2006 / Rules and Regulations

and expeditious flow of civil air traffic. Control 1487L [Amended] lowering the airspace floor from 2,000
The purpose of Article 12 and Annex 11 That airspace extending upward from feet above ground level (AGL) to 700
is to ensure that civil aircraft operations 8,000 feet MSL within 149.5 miles of the AGL. Additionally, outside the vicinity
on international air routes are Anchorage VOR/DME clockwise from the of the airport this action lowers the
performed under uniform conditions. 090° radial to the 185° radial of the airspace floor from 2,000 AGL to 1,200
The International Standards and Anchorage VOR/DME; and that airspace feet AGL within a 73-mile radius of the
extending upward from 5,500 feet MSL
Recommended Practices in Annex 11 within the area bounded by a line beginning
St. Paul Island Airport. The FAA is
apply to airspace under the jurisdiction at lat. 58°19′58″ N., long. 148°55′07″ W.; to taking this action to provide additional
of a contracting state, derived from lat. 59°08′35″ N., long. 147°16′04″ W.; thence controlled airspace for aircraft
ICAO. Annex 11 provisions apply when counterclockwise via the arc of a 149.5-mile instrument flight rules (IFR) operations
air traffic services are provided and a radius centered on the Anchorage VOR/DME at the St. Paul Island Airport.
contracting state accepts the to the intersection of the 149.5-mile radius DATES: Effective Date: 0901 UTC, August
responsibility of providing air traffic arc and a point 12 miles from and parallel 3, 2006.
services over high seas or in airspace of to the U.S. coastline; thence southeast 12
miles from and parallel to the U.S. coastline FOR FURTHER INFORMATION CONTACT: Ken
undetermined sovereignty. A to a point 12 miles offshore on the Vancouver McElroy, Airspace and Rules, Office of
contracting state accepting this FIR boundary; to lat. 54°32′57″ N., long. System Operations Airspace and AIM,
responsibility may apply the 133°11′29″ W.; to lat. 54°00′00″ N., long. Federal Aviation Administration, 800
International Standards and 136°00′00″ W.; to lat. 52°43′00″ N., long. Independence Avenue, SW.,
Recommended Practices that are 135°00′00″ W.; to lat. 56°45′42″ N., long. Washington, DC 20591; telephone: (202)
consistent with standards and practices 151°45′00″ W.; to the point of beginning; and
267–8783.
utilized in its domestic jurisdiction. that airspace extending upward from 1,200
feet MSL within the area bounded by a line SUPPLEMENTARY INFORMATION:
In accordance with Article 3 of the
beginning at lat. 59°33′25″ N., long.
Convention, state-owned aircraft are History
141°03′22″ W.; thence southeast 12 miles
exempt from the Standards and from and parallel to the U.S. coastline to lat. On April 13, 2006, the FAA published
Recommended Practices of Annex 11. 58°56′18″ N., long. 138°45′19″ W.; to lat. in the Federal Register a notice of
The United States is a contracting state 58°40′00″ N., long. 139°30′00″ W.; to lat. proposed rulemaking to modify the
to the Convention. Article 3(d) of the 59°00′00″ N., long. 141°10′00″ W.; to the Control 1234L offshore airspace area in
Convention provides that participating point of beginning, and that airspace within Alaska (71 FR 19148). Interested parties
state aircraft will be operated in 85 miles of the Biorka Island VORTAC, and
that airspace within 42 miles of the
were invited to participate in this
international airspace with due regard rulemaking effort by submitting written
for the safety of civil aircraft. Since this Middleton Island VOR/DME, and that
airspace within 30 miles of the Glacier River comments on the proposal. No
action involves, in part, the designation comments were received.
NDB; and that airspace extending upward
of navigable airspace outside the United from 700 feet MSL within 14 miles of the Offshore Airspace Areas are
States, the Administrator is consulting Biorka Island VORTAC and within 4 miles published in paragraph 6007 of FAA
with the Secretary of State and the west and 8 miles east of the Biorka Island Order 7400.9N dated September 1, 2005
Secretary of Defense in accordance with VORTAC 209° radial extending to 16 miles and effective September 15, 2005, which
the provisions of Executive Order southwest of the VORTAC. The portion is incorporated by reference in 14 CFR
10854. within Canada is excluded.
71.1. The Offshore Airspace Areas listed
List of Subjects in 14 CFR Part 71 * * * * * in this document will be published
Issued in Washington, DC on May 31, subsequently in the Order.
Airspace, Incorporation by reference, 2006.
Navigation (air). The Rule
Edith V. Parish,
The Amendment Manager, Airspace and Rules. This action amends Title 14 Code of
[FR Doc. E6–8848 Filed 6–6–06; 8:45 am] Federal Regulations (14 CFR) part 71 by
■ In consideration of the foregoing, the modifying Control 1234L Offshore
BILLING CODE 4910–13–P
Federal Aviation Administration Airspace Area, AK by lowering the floor
amends 14 CFR part 71 as follows: to 700 feet AGL in the vicinity of the St.
DEPARTMENT OF TRANSPORTATION Paul Island Airport, AK, and 1,200 feet
PART 71—DESIGNATION OF CLASS A, AGL within a 73-mile radius of the
B, C, D AND E AIRSPACE AREAS; AIR airport. The action is to establish
Federal Aviation Administration
TRAFFIC SERVICE ROUTES; AND controlled airspace to support IFR
REPORTING POINTS operations at the St. Paul Island Airport,
14 CFR Part 71
■ 1. The authority citation for part 71 Alaska. The FAA Instrument Flight
[Docket No. FAA–2006–23708; Airspace
continues to read as follows: Procedures Production and
Docket No. 06–AAL–1]
Maintenance Branch developed new
Authority: 49 U.S.C. 106(g), 40103, 40113, RIN–2120–AA66 instrument approach procedures for the
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389. St. Paul Island Airport. New controlled
Modification of Control 1234L Offshore airspace extending upward from 700
§ 71.1 [Amended] Airspace Area; AK feet AGL and 1,200 feet AGL in
■ 2. The incorporation by reference in AGENCY: Federal Aviation international airspace is created by this
14 CFR 71.1 of the FAA Order 7400.9N, Administration (FAA), DOT. action.
Airspace Designations and Reporting ACTION: Final rule. The FAA has determined that this
Points, dated September 1, 2005, and regulation only involves an established
sroberts on PROD1PC70 with RULES

SUMMARY: This action amends Control body of technical regulations for which
effective September 15, 2005, is
amended as follows: 1234L offshore airspace area in Alaska. frequent and routine amendments are
Specifically, this action modifies necessary to keep them operationally
Paragraph 6007 Offshore airspace areas. Control 1234L in the immediate vicinity current. Therefore, this regulation: (1) Is
* * * * * of the Saint Paul Island Airport, AK, by not a ‘‘significant regulatory action’’

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Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Rules and Regulations 32827

under Executive Order 12866; (2) is not States, the Administrator is consulting DEPARTMENT OF HEALTH AND
a ‘‘significant rule’’ under Department of with the Secretary of State and the HUMAN SERVICES
Transportation (DOT) Regulatory Secretary of Defense in accordance with
Policies and Procedures (44 FR 11034; the provisions of Executive Order Food and Drug Administration
February 26, 1979); and (3) does not 10854.
warrant preparation of a regulatory 21 CFR Part 50
evaluation as the anticipated impact is List of Subjects in 14 CFR Part 71
so minimal. Since this is a routine Airspace, Incorporation by reference, RIN 0910–AC25
matter that will only affect air traffic Navigation (air).
procedures and air navigation, it is
The Amendment [Docket No. 2003N–0355]
certified that this proposed rule, when
promulgated, will not have a significant In consideration of the foregoing, the Medical Devices; Exception From
economic impact on a substantial Federal Aviation Administration General Requirements for Informed
number of small entities under the amends 14 CFR part 71 as follows: Consent
criteria of the Regulatory Flexibility Act.
PART 71—DESIGNATION OF CLASS A, AGENCY: Food and Drug Administration,
ICAO Considerations
B, C, D AND E AIRSPACE AREAS; AIR HHS.
As part of this rule relates to TRAFFIC SERVICE ROUTES; AND ACTION: Interim final rule.
navigable airspace outside the United REPORTING POINTS
States, the notice of this action is SUMMARY: The Food and Drug
submitted in accordance with the ■ 1. The authority citation for part 71 Administration (FDA) is issuing this
International Civil Aviation continues to read as follows: interim final rule to amend its
Organization (ICAO) International Authority: 49 U.S.C. 106(g), 40103, 40113, regulations to establish a new exception
Standards and Recommended Practices. 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– from the general requirements for
The application of International 1963 Comp., p. 389. informed consent, to permit the use of
Standards and Recommended Practices investigational in vitro diagnostic
by the FAA, Office of System § 71.1 [Amended]
devices to identify chemical, biological,
Operations Airspace and AIM, Airspace ■ 2. The incorporation by reference in radiological, or nuclear agents without
& Rules, in areas outside the United 14 CFR 71.1 of the FAA Order 7400.9N, informed consent in certain
States domestic airspace, is governed by Airspace Designations and Reporting circumstances. The agency is taking this
the Convention on International Civil Points, dated September 1, 2005, and action because it is concerned that,
Aviation. Specifically, the FAA is effective September 15, 2005, is during a potential terrorism event or
governed by Article 12 and Annex 11, amended as follows: other potential public health emergency,
which pertain to the establishment of
Paragraph 6007 Offshore airspace areas. delaying the testing of specimens to
necessary air navigational facilities and
* * * * * obtain informed consent may threaten
services to promote the safe, orderly,
the life of the subject. In many
and expeditious flow of civil air traffic. Control 1234L [Amended] instances, there may also be others who
The purpose of Article 12 and Annex 11
That airspace extending upward from 700 have been exposed to, or who may be
is to ensure that civil aircraft operations feet above the surface within 8 miles west at risk of exposure to, a dangerous
on international air routes are and 6 miles east of the 360° bearing from the
performed under uniform conditions. chemical, biological, radiological, or
St. Paul Island Airport to 14 miles north of nuclear agent, thus necessitating
The International Standards and the St. Paul Island Airport, and within 6
Recommended Practices in Annex 11 identification of the agent as soon as
miles west and 8 miles east of the 172°
apply to airspace under the jurisdiction bearing from the St. Paul Island Airport to 15 possible. FDA is creating this exception
of a contracting state, derived from miles south of the St. Paul Island Airport; to help ensure that individuals who may
ICAO. Annex 11 provisions apply when and that airspace extending upward from have been exposed to a chemical,
air traffic services are provided and a 1,200 feet above the surface within a 73-mile biological, radiological, or nuclear agent
contracting state accepts the radius of the St. Paul Island Airport, and the are able to benefit from the timely use
airspace extending upward from 1,200 MSL of the most appropriate diagnostic
responsibility of providing air traffic within a 72.8-mile radius of Chignik Airport,
services over high seas or in airspace of devices, including those that are
AK; and that airspace extending upward from investigational.
undetermined sovereignty. A 2,000 feet above the surface within an area
contracting state accepting this bounded by a line beginning at lat. 58°06′57″ DATES: This rule is effective June 7,
responsibility may apply the N., long. 160°00′00″ W., south along long. 2006. Submit written or electronic
International Standards and 160°00′00″ W. until it intersects the comments by August 7, 2006.
Recommended Practices that are Anchorage Air Route Traffic Control Center
boundary; thence southwest, northwest, ADDRESSES: Submit written comments
consistent with standards and practices to the Division of Dockets Management
utilized in its domestic jurisdiction. north, and northeast along the Anchorage Air
Route Traffic Control Center boundary to lat. (HFA–305), Food and Drug
In accordance with Article 3 of the
62°35′00″ N., long. 175°00′00″ W.; to lat. Administration, 5630 Fishers Lane, rm.
Convention, state-owned aircraft are 59°59′57″ N., long. 168°00′08″ W.; to lat. 1061, Rockville, MD 20852. Submit
exempt from the Standards and 57°45′57″ N., long. 161°46′08″ W.; to the electronic comments to http://
Recommended Practices of Annex 11. point of beginning. www.fda.gov/dockets/ecomments.
The United States is a contracting state * * * * *
to the Convention. Article 3(d) of the FOR FURTHER INFORMATION CONTACT:
Convention provides that participating Issued in Washington, DC on May 31, Claudia M. Gaffey, Center for Devices
2006.
sroberts on PROD1PC70 with RULES

state aircraft will be operated in and Radiological Health (HFZ–440),


international airspace with due regard Edith V. Parish, Food and Drug Administration, 2098
for the safety of civil aircraft. Since this Manager, Airspace and Rules. Gaither Rd., Rockville, MD 20850, 240–
action involves, in part, the designation [FR Doc. E6–8850 Filed 6–6–06; 8:45 am] 276–0496, ext. 109.
of navigable airspace outside the United BILLING CODE 4910–13–P SUPPLEMENTARY INFORMATION:

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