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Federal Register / Vol. 72, No.

152 / Wednesday, August 8, 2007 / Rules and Regulations 44379

DEPARTMENT OF TRANSPORTATION 1. FAA Public Inquiry Center (APA– The Rule


200), FAA Headquarters Building, 800
Federal Aviation Administration Independence Avenue, SW., This amendment to 14 CFR part 97 is
Washington, DC 20591; or effective upon publication of each
14 CFR Part 97 separate SIAP and/or Weather Takeoff
2. The FAA Regional Office of the
Minimums as contained in the
[Docket No. 30562 Amdt. No. 3229] region in which the affected airport is
transmittal. Some SIAP and/or Weather
located.
Standard Instrument Approach Takeoff Minimums amendments may
Procedures, Weather Takeoff By Subscription—Copies of all SIAPs have been previously issued by the FAA
Minimums; Miscellaneous and Weather Takeoff Minimums mailed in a Flight Data Center (FDC) Notice to
Amendments once every 2 weeks, are for sale by the Airmen (NOTAM) as an emergency
Superintendent of Documents, U.S. action of immediate flight safety relating
AGENCY: Federal Aviation Government Printing Office,
Administration (FAA), DOT. directly to published aeronautical
Washington, DC 20402. charts. The circumstances which
ACTION: Final rule.
FOR FURTHER INFORMATION CONTACT: created the need for some SIAP, and/or
SUMMARY: This amendment establishes, Donald P. Pate, Flight Procedure Weather Takeoff Minimums
amends, suspends, or revokes Standard Standards Branch (AFS–420), Flight amendments may require making them
Instrument Approach Procedures Technologies and Programs Division, effective in less than 30 days. For the
(SIAPs) and/or Weather Takeoff Flight Standards Service, Federal remaining SIAPs and/or Weather
Minimums for operations at certain Aviation Administration, Mike Takeoff Minimums, an effective date at
airports. These regulatory actions are Monroney Aeronautical Center, 6500 least 30 days after publication is
needed because of the adoption of new South MacArthur Blvd., Oklahoma City, provided.
or revised criteria, or because of changes OK. 73169 (Mail Address: P.O. Box
Further, the SIAPs and/or Weather
occurring in the National Airspace 25082 Oklahoma City, OK. 73125)
Takeoff Minimums contained in this
System, such as the commissioning of telephone: (405) 954–4164.
new navigational facilities, addition of amendment are based on the criteria
new obstacles, or changes in air traffic SUPPLEMENTARY INFORMATION: This contained in the U.S. Standard for
requirements. These changes are amendment to Title 14 of the Code of Terminal Instrument Procedures
designed to provide safe and efficient Federal Regulations, Part 97 (14 CFR (TERPS). In developing these SIAPs
use of the navigable airspace and to part 97), establishes, amends, suspends, and/or Weather Takeoff Minimums, the
promote safe flight operations under or revokes SIAPs and/or Weather TERPS criteria were applied to the
instrument flight rules at the affected Takeoff Minimums. The complete conditions existing or anticipated at the
airports. regulatory description of each SIAP affected airports. Because of the close
and/or Weather Takeoff Minimums is and immediate relationship between
DATES: This rule is effective August 8, contained in official FAA form
2007. The compliance date for each these SIAPs and/or Weather Takeoff
documents which are incorporated by Minimums and safety in air commerce,
SIAP and/or Weather Takeoff reference in this amendment under 5
Minimums is specified in the I find that notice and public procedure
U.S.C. 552(a), 1 CFR part 51, and 14
amendatory provisions. before adopting these SIAPs and/or
CFR part 97.20. The applicable FAA
The incorporation by reference of Weather Takeoff Minimums are
Forms are identified as FAA Forms
certain publications listed in the 8260–3, 8260–4, 8260–5 and 8260–15A. impracticable and contrary to the public
regulations is approved by the Director Materials incorporated by reference are interest and, where applicable, that
of the Federal Register as of August 8, available for examination or purchase as good cause exists for making some
2007. stated above. SIAPs and/or Weather Takeoff
ADDRESSES: Availability of matters Minimums effective in less than 30
The large number of SIAPs and/or days.
incorporated by reference in the
Weather Takeoff Minimums, their
amendment is as follows:
For Examination— complex nature, and the need for a Conclusion
1. FAA Rules Docket, FAA special format make their verbatim
publication in the Federal Register The FAA has determined that this
Headquarters Building, 800
expensive and impractical. Further, regulation only involves an established
Independence Avenue, SW.,
airmen do not use the regulatory text of body of technical regulations for which
Washington, DC 20591;
2. The FAA Regional Office of the the SIAPs and/or Weather Takeoff frequent and routine amendments are
region in which the affected airport is Minimums but refer to their depiction necessary to keep them operationally
located; on charts printed by publishers of current. It, therefore—(1) Is not a
3. The National Flight Procedures aeronautical materials. Thus, the ‘‘significant regulatory action’’ under
Office, 6500 South MacArthur Blvd., advantages of incorporation by reference Executive Order 12866; (2) is not a
Oklahoma City, OK 73169 or, are realized and publication of the ‘‘significant rule’’ under DOT
4. The National Archives and Records complete description of each SIAP and/ Regulatory Policies and Procedures (44
Administration (NARA). For or Weather Takeoff Minimums FR 11034; February 26, 1979); and (3)
information on the availability of this contained in FAA form documents is does not warrant preparation of a
material at NARA, call 202–741–6030, unnecessary. The provisions of this regulatory evaluation as the anticipated
or go to: http://www.archives.gov/ amendment state the affected CFR impact is so minimal. For the same
federal_register/ sections, with the types and effective reason, the FAA certifies that this
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code_of_federal_regulations/ dates of the SIAPs and/or Weather amendment will not have a significant
ibr_locations.html. Takeoff Minimums. This amendment economic impact on a substantial
For Purchase—Individual SIAP and also identifies the airport, its location, number of small entities under the
Weather Takeoff Minimums copies may the procedure identification and the
criteria of the Regulatory Flexibility Act.
be obtained from: amendment number.

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44380 Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations

List of Subjects in 14 CFR Part 97 New York, NY, LaGuardia, RNAV (GPS) Y special control that will apply to this
RWY 4, Amdt 2 device is the guidance document
Air Traffic Control, Airports, New York, NY, LaGuardia, RNAV (GPS) Y
Incorporation by reference, and entitled ‘‘Class II Special Controls
RWY 22, Amdt 2
Navigation (Air). Guidance Document: In Vitro HIV Drug
Sioux Falls, SD, Joss Foss Field, Takeoff
Minimums and Obstacle DP, Amdt 7 Resistance Genotype Assay.’’ FDA is
Issued in Washington, DC on July 27, 2007. classifying the device into class II
Houston, TX, Houston Executive, RNAV
James J. Ballough, (special controls) in order to provide a
(GPS) RWY 18, Orig
Director, Flight Standards Service. Houston, TX, Houston Executive, RNAV reasonable assurance of safety and
Adoption of the Amendment (GPS) RWY 36, Orig effectiveness of this device. Elsewhere
Houston, TX, Houston Executive, Takeoff in this issue of the Federal Register,
■ Accordingly, pursuant to the authority Minimums and Obstacle DP, Orig FDA is announcing the availability of
delegated to me, under Title 14, Code of Menomonie, WI, Menomonie Municipal-
the guidance document that will serve
Federal Regulations, Part 97 (14 CFR Score Field, RNAV (GPS) RWY 27, Orig
Menomonie, WI, Menomonie Municipal- as the special control for this device.
part 97) is amended by establishing, DATES: This rule becomes effective
Score Field, RNAV (GPS) RWY 9, Orig
amending, suspending, or revoking Norfolk, VA, Hampton Roads Executive, NDB September 7, 2007. The classification of
Standard Instrument Approach RWY 2, Amdt 7 this device into class II became effective
Procedures and Weather Takeoff Norfolk, VA, Hampton Roads Executive, on September 26, 2001.
Minimums effective at 0901 UTC on the RNAV (GPS) RWY 10, Orig
FOR FURTHER INFORMATION CONTACT:
dates specified, as follows: Norfolk, VA, Hampton Roads Executive,
RNAV (GPS) RWY 28, Orig Nathaniel L. Geary, Center for Biologics
PART 97—STANDARD INSTRUMENT Norfolk, VA, Hampton Roads Executive, GPS Evaluation and Research, Food and
APPROACH PROCEDURES RWY 10, Orig-A, CANCELLED Drug Administration, 1401 Rockville
Norfolk, VA, Hampton Roads Executive, GPS Pike, suite 200N, Rockville, MD 20852,
■ 1. The authority citation for part 97 RWY 28, Orig-A, CANCELLED 301–827–6210.
continues to read as follows: Norfolk, VA, Hampton Roads Executive,
SUPPLEMENTARY INFORMATION:
Takeoff Minimums and Obstacle DP, Amdt
Authority: 49 U.S.C. 106(g), 40103, 40106,
1 I. Background
40113, 40114, 40120, 44502, 44514, 44701,
44719, 44721–44722. Effective 27 SEP 2007 In accordance with section 513(f)(1) of
■ 2. Part 97 is amended to read as Chicago, IL, Chicago-O’Hare Intl, RNAV the Federal Food, Drug, and Cosmetic
follows: (GPS) RWY 32L, Amdt 2A Act (the act) (21 U.S.C. 360c(f)(1)),
The FAA published several Amendments devices that were not in commercial
Effective 30 AUG 2007 in Docket No. 30558, Amdt No. 3225 to Part distribution before May 28, 1976, the
Grand Canyon, AZ, Grand Canyon National 97 Of the Federal Aviation Regulations (Vol. date of enactment of the Medical Device
Park, Takeoff Minimums and Obstacle DP, 72, FR No. 135, Page 38755; dated Monday, Amendments of 1976, generally referred
Orig July 16, 2007) under section 97.33, effective to as postamendments devices, are
Phoenix, AZ, Phoenix Deer Valley, RNAV 30 August 2007, which is hereby
RESCINDED as follows:
classified automatically by statute into
(GPS)-B, Orig-A
Phoenix, AZ, Phoenix Deer Valley, RNAV
class III without any FDA rulemaking
Miami, FL, Miami Intl, RNAV (RNP) Y RWY
(GPS) RWY 25L, Orig-B 9, Orig
process. These devices remain in class
Sylvania, GA, Plantation Airpark, NDB RWY Miami, FL, Miami Intl, RNAV (GPS) Z RWY III and require premarket approval,
23, Amdt 2 9, Amdt 1 unless and until the device is classified
Westfield/Springfield, MA, Barnes Muni, ILS Miami, FL, Miami Intl, ILS OR LOC RWY 9, or reclassified into class I or II, or FDA
OR LOC RWY 20, Amdt 6 Amdt 10 issues an order finding the device to be
Westfield/Springfield, MA, Barnes Muni, substantially equivalent, in accordance
RNAV (GPS) RWY 20, Orig [FR Doc. E7–15134 Filed 8–7–07; 8:45 am]
with section 513(i) of the act, to a
Westfield/Springfield, MA, Barnes Muni, BILLING CODE 4910–13–P
predicate device that does not require
GPS RWY 20, Orig-A, CANCELLED
Lee’s Summit, MO, Lee’s Summit Municipal,
premarket approval. FDA determines
Takeoff Minimums and Obstacle DP, Orig whether new devices are substantially
DEPARTMENT OF HEALTH AND equivalent to predicate devices by
Aberdeen/Amory, MS, Monroe County, HUMAN SERVICES
RNAV (GPS) RWY 18, Orig means of premarket notification
Aberdeen/Amory, MS, Monroe County, Food and Drug Administration procedures in section 510(k) of the act
RNAV (GPS) RWY 36, Orig (21 U.S.C. 360(k)) and part 807 (21 CFR
Aberdeen/Amory, MS, Monroe County, part 807) of FDA’s regulations.
Takeoff Minimums and Obstacle DP, Orig 21 CFR Part 866
Section 513(f)(2) of the act provides
Erwin, NC, Harnett County, Takeoff [Docket No. 2007N–0294] that any person who submits a
Minimums and Obstacle DP, Orig
premarket notification under section
Laconia, NH, Laconia, Muni, NDB RWY 8, Medical Devices: Immunology and
Amdt 9 510(k) of the act for a device that has not
Microbiology Devices: Classification of previously been classified may, within
Laconia, NH, Laconia, Muni, ILS OR LOC
In Vitro Human Immunodeficiency 30 days after receiving an order
RWY 8, Amdt 1
Laconia, NH, Laconia, Muni, RNAV (GPS) Virus Drug Resistance Genotype classifying the device in class III under
RWY 8, Orig Assay section 513(f)(1) of the act, request FDA
Laconia, NH, Laconia, Muni, RNAV (GPS) AGENCY: Food and Drug Administration, to classify the device under the criteria
RWY 26, Orig set forth in section 513(a)(1) of the act.
HHS.
Laconia, NH, Laconia, Muni, GPS RWY 26, FDA shall, within 60 days of receiving
Orig-A, CANCELLED ACTION: Final rule.
such a request, classify the device by
New York, NY, LaGuardia, ILS OR LOC RWY
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SUMMARY: The Food and Drug written order. This classification shall
4, Amdt 35
New York, NY, LaGuardia, RNAV (RNP) Z Administration (FDA) is classifying an be the initial classification of the device.
RWY 4, Orig in vitro human immunodeficiency virus In accordance with section 513(f)(1) of
New York, NY, LaGuardia, RNAV (RNP) Z (HIV) drug resistance genotype assay the act, FDA issued an order on June 27,
RWY 22, Orig into class II (special controls). The 2001, classifying into class III the

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