57746 Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Rules and Regulations 

Issued in Renton, Washington, on 

September 26, 2005. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 05–19876 Filed 10–3–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2005–21166; Airspace 

Docket No. 05–AWP–4] 

Establishment of Class E Airspace; 

Hana, HI 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action establishes a Class 

E airspace area at Hana, HI. The 

establishment of an Area Navigation 

(RNAV) Global Positioning System 

(GPS) Instrument Approach Procedures 

(IAP) RNAV (GPS) to Runway (RWY) 26 

IAP and a RNAV Departure Procedure 

(DP) at Hana Airport, Hana, HI has made 

this action necessary. Additional 

controlled airspace extending upward 

from 700 feet or more above the surface 

of the earth is needed to contain aircraft 

executing this RNAV (GPS) IAP and 

RNAV DP. The intended effect of this 

action is to provide adequate controlled 

airspace for Instrument Flight Rules 

operations at Hana Airport, Hana, HI. 

DATES: Effective 0901 UTC October 27, 

2005. 

FOR FURTHER INFORMATION CONTACT: 

Debra Trindle, The Office of the 

Regional Western Terminal Operations, 

Federal Aviation Administration, at 

15000 Aviation Boulevard, Lawndale, 

California 90261, telephone (310) 725–

6613. 

SUPPLEMENTARY INFORMATION: 

History 

On August 3, 2005, the FAA proposed 

to amend 14 CFR parts 71 by modifying 

the Class E airspace area at Hana 

Airport, HI (05 FR 15314). Additional 

controlled airspace extending upward 

from 700 feet or more above the surface 

is needed to contain aircraft executing 

the RNAV (GPS) (RWY) 26 IAP and 

RNAV DP at Hana Airport, Hana, HI. 

This action will provide adequate 

controlled airspace for aircraft executing 

the RNAV (GPS) (RWY) 26 IAP and 

RNAV DP at Hana Airport, Hana, HI. 

Interested parties were invited to 

participate in this rulemaking, 

proceeding by submitting written 

comments on the proposal to the FAA. 

No comments to the proposal were 

received. Class E airspace designations 

for airspace extending from 700 feet or 

more above the surface of the earth are 

published in paragraph 6005 of FAA 

Order 7400.9N, dated August September 

1, 2005, and effective September 16, 

2005, which is incorporated by 

reference in 14 CFR 71.1. The Class E 

airspace designation listed in this 

document will be published 

subsequently in the Order. 

The Rule 

This amendment to 14 CFR part 71 

modifies the Class E airspace area at 

Hana Airport, HI. The establishment of 

a RNAV (GPS) (RWY) 26 IAP and RNAV 

DP at Hana Airport has made this action 

necessary. The effect of this action will 

provide adequate airspace for aircraft 

executing the RNAV (GPS) (RWY) 26 

IAP and RNAV DP at Hana Airport, 

Hana, HI. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation—(1) 

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

Regulatory Evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule will not have 

a significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

CLASS B, CLASS C, CLASS D, AND 

CLASS E AIRSPACE AREAS; ROUTES; 

AND REPORTING POINTS. 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of the Federal Aviation 

Administration Order 7400.9N, 

Airspace Designations and Reporting 

Points, dated September 1, 2005, and 

effective September 16, 2005, is 

amended as follows: 

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

* * * * * 

AWP HI E5 Hana, HI [New] 

Hana, HI 

(Lat. 20°47′44′′ N, long. 156°00′52′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.3-mile 

radius of the Hana Airport. 

* * * * * 

Dated: Issued in Los Angeles, California, 

on September 21, 2005. 

Leonard Mobley, 

Acting Area Director, Western Terminal 

Operations. 

[FR Doc. 05–19855 Filed 10–3–05; 8:45am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30458; Amdt. No. 3135] 

Standard Instrument Approach 

Procedures; Miscellaneous 

Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This amendment amends 

Standard Instrument Approach 

Procedures (SIAPs) for operations at 

certain airports. These regulatory 

actions are needed because of changes 

occurring in the National Airspace 

System, such as the commissioning of 

new navigational facilities, addition of 

new obstacles, or changes in air traffic 

requirements. These changes are 

designed to provide safe and efficient 

use of the navigable airspace and to 

promote safe flight operations under 

instrument flight rules at the affected 

airports. 

DATES: This rule is effective October 4, 

2005. The compliance date for each 

SIAP is specified in the amendatory 

provisions. 

The incorporation by reference of 

certain publications listed in the 

regulations is approved by the Director 

Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Rules and Regulations 57747 

of the Federal Register as of October 4, 

2005. 

ADDRESSES: Availability of matter 

incorporated by reference in the 

amendment is as follows: 

For Examination—

1. FAA Rules Docket, FAA 

Headquarters Building, 800 

Independence Ave, SW., Washington, 

DC 20591; 

2. The FAA Regional Office of the 

region in which affected airport is 

located; or 

3. The National Flight Procedures 

Office, 6500 South MacArthur Blvd., 

Oklahoma City, OK 73169 or, 

4. The National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

For Purchase—Individual SIAP 

copies may be obtained from: 

1. FAA Public Inquiry Center (APA–

200), FAA Headquarters Building, 800 

Independence Avenue, SW., 

Washington, DC 20591; or 

2. The FAA Regional Office of the 

region in which the affected airport is 

located. 

By Subscription—Copies of all SIAPs, 

mailed once every 2 weeks, are for sale 

by the Superintendent of Documents, 

U.S. Government Printing Office, 

Washington, DC 20402. 

FOR FURTHER INFORMATION CONTACT: 

Donald P. Pate, Flight Procedure 

Standards Branch (AFS–420), Flight 

Technologies and Programs Division, 

Flight Standards Service, Federal 

Aviation Administration, Mike 

Monroney Aeronautical Center, 6500 

South MacArthur Blvd., Oklahoma City, 

OK 73169 (Mail Address: P.O. Box 

25082 Oklahoma City, OK 73125) 

telephone: (405) 954–4164. 

SUPPLEMENTARY INFORMATION: This 

amendment to Title 14, Code of Federal 

Regulations, Part 97 (14 CFR Part 97) 

amends Standard Instrument Approach 

Procedures (SIAPs). The complete 

regulatory description of each SIAP is 

contained in the appropriate FAA Form 

8260, as modified by the the National 

Flight Data Center (FDC)/Permanent 

Notice to Airmen (P–NOTAM), which is 

incorporated by reference in the 

amendment under 5 U.S.C. 552(a), 1 

CFR part 51, and § 97.20 of the Code of 

Federal Regulations. Materials 

incorporated by reference are available 

for examination or purchase as stated 

above. 

The large number of SIAPs, their 

complex nature, and the need for a 

special format make their verbatim 

publication in the Federal Register 

expensive and impractical. Further, 

airmen do not use the regulatory text of 

the SIAPs, but refer to their graphic 

depiction on charts printed by 

publishers of aeronautical materials. 

Thus, the advantages of incorporation 

by reference are realized and 

publication of the complete description 

of each SIAP contained in FAA form 

documents is unnecessary. The 

provisions of this amendment state the 

affected CFR sections, with the types 

and effective dates of the SIAPs. This 

amendment also identifies the airport, 

its location, the procedure identification 

and the amendment number. 

The Rule 

This amendment to 14 CFR part 97 is 

effective upon publication of each 

separate SIAP as amended in the 

transmittal. For safety and timeliness of 

change considerations, this amendment 

incorporates only specific changes 

contained for each SIAP as modified by 

FDC/P–NOTAMs. 

The SIAPs, as modified by FDC P–

NOTAM, and contained in this 

amendment are based on the criteria 

contained in the U.S. Standard for 

Terminal Instrument Procedures 

(TERPS). In developing these chart 

changes to SIAPs, the TERPS criteria 

were applied to only these specific 

conditions existing at the affected 

airports. All SIAP amendments in this 

rule have been previously issued by the 

FAA in a FDC NOTAM as an emergency 

action of immediate flight safety relating 

directly to published aeronautical 

charts. The circumstances which 

created the need for all these SIAP 

amendments requires making them 

effective in less than 30 days. 

Further, the SIAPs contained in this 

amendment are based on the criteria 

contained in TERPS. Because of the 

close and immediate relationship 

between these SIAPs and safety in air 

commerce, I find that notice and public 

procedure before adopting these SIAPs 

are impracticable and contrary to the 

public interest and, where applicable, 

that good cause exists for making these 

SIAPs effective in less than 30 days. 

Conclusion 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore—(1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. For the same 

reason, the FAA certifies that this 

amendment will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 97 

Air Traffic Control, Airports, 

Incorporation by reference, and 

Navigation (Air). 

Issued in Washington, DC, on September 

23, 2005. 

James J. Ballough, 

Director, Flight Standards Service. 

Adoption of the Amendment 

■ Accordingly, pursuant to the authority 

delegated to me, Title 14, Code of 

Federal regulations, Part 97, 14 CFR part 

97, is amended by amending Standard 

Instrument Approach Procedures, 

effective at 0901 UTC on the dates 

specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40113, 40114, 40120, 44502, 44514, 44701, 

44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 

and 97.35 [Amended] 

By amending: § 97.23 VOR, VOR/ 

DME, VOR or TACAN, and VOR/DME 

or TACAN; § 97.25 LOC, LOC/DME, 

LDA, LDA/DME, SDF, SDF/DME; 

§ 97.27 NDB, NDB/DME; § 97.29 ILS, 

ILS/DME, ISMLS, MLS/DME, MLS/ 

RNAV; § 97.31 RADAR SIAPs; § 97.33 

RNAV SIAPs; and § 97.35 COPTER 

SIAPs, Identified as follows: 

* * * Effective upon publication 

FDC date State City Airport FDC No. Subject 

09/19/05 ...... WY Cheyenne ...................... Cheyenne Regional/Jerry Olson 

Field.

5/8498 RNAV (GPS) Rwy 27, Orig-A 

57748 Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Rules and Regulations 

FDC date State City Airport FDC No. Subject 

09/19/05 ...... ID Idaho Falls ..................... Idaho Falls Regional ......................... 5/8505 NDB Rwy 20, Amdt 10B 

09/19/05 ...... ID Idaho Falls ..................... Idaho Falls Regional ......................... 5/8520 ILS Rwy 20, Amdt 11C 

09/19/05 ...... UT Cedar City ..................... Cedar City Regional .......................... 5/8521 ILS OR LOC Rwy 20, Amdt 3C 

09/19/05 ...... UT Provo ............................. Provo Muni ........................................ 5/8522 ILS OR LOC/DME Rwy 13, Orig-A 

09/19/05 ...... UT Roosevelt ....................... Roosevelt Muni .................................. 5/8523 RNAV (GPS) Rwy 25, Orig-A 

09/19/05 ...... UT Roosevelt ....................... Roosevelt Muni .................................. 5/8524 VOR/DME RNAV Rwy 25, Amdt 2A 

09/19/05 ...... UT Provo ............................. Provo Muni ........................................ 5/8526 VOR/DME Rwy 13, Amdt 1A 

09/19/05 ...... UT Provo ............................. Provo Muni ........................................ 5/8527 VOR Rwy 13, Amdt 3A

09/19/05 ...... UT Moab .............................. Canyon Lands Field .......................... 5/8528 VOR–A, Amdt 10A 

[FR Doc. 05–19745 Filed 10–3–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. 2005N–0341] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

AFP-L3% Immunological Test Systems 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying 

AFP-L3% (alpha-fetoprotein L3 

subfraction) immunological test systems 

into class II (special controls). The 

special control that will apply to the 

device is the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: AFP-L3% 

Immunological Test Systems.’’ The 

agency is classifying the device into 

class II (special controls) in order to 

provide a reasonable assurance of safety 

and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of a guidance document that 

will serve as the special control for the 

device. 

DATES: This rule is effective November 

3, 2005. The classification was effective 

May 19, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Maria Chan, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0496. 

SUPPLEMENTARY INFORMATION: 

I. What is the Background of this 

Rulemaking? 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976, the 

date of enactment of the Medical Device 

Amendments of 1976 (the amendments), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the act 

(21 U.S.C. 360(k)) and 21 CFR part 807 

of FDA’s regulations. 

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification (section 

513(f)(2) of the act). 

In accordance with section 513(f)(1) of 

the act, FDA issued an order on April 

1, 2005, classifying the Wako LBA 

(liquid-phase binding assay) AFP-L3 in 

class III, because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device that was subsequently 

reclassified into class I or class II. On 

April 6, 2005, Wako Chemical USA, 

Inc., submitted a petition requesting 

classification of the Wako AFP-L3 Test 

System under section 513(f)(2) of the 

act. The manufacturer recommended 

that the device be classified into class II. 

In accordance with 513(f)(2) of the 

act, FDA reviewed the petition in order 

to classify the device under the criteria 

for classification set forth in 513(a)(1) of 

the act. Devices are to be classified into 

class II if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA determined that the Wako LBA 

AFP-L3 Test System can be classified 

into class II with the establishment of 

special controls. FDA believes these 

special controls will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

The device is assigned the generic 

name AFP-L3% immunological test 

system and it is identified as an in vitro 

device that consists of reagents and an 

automated instrument used to 

quantitatively measure, by 

immunochemical techniques, AFP and 

AFP-L3 subfraction in human serum. 

The device is intended for in vitro 

diagnostic use as an aid in the risk 

assessment of patients with chronic 

liver disease for development of 

hepatocellular carcinoma, in 

conjunction with other laboratory 

findings, imaging studies, and clinical 

assessment. 

FDA has identified the risks to health 

associated with this type of device as 

inappropriate risk assessment and 

improper patient management. Failure 

of the system to perform as indicated, or 

error in interpretation of results, could 

lead to inappropriate risk assessment 

and improper management of patients 

with chronic liver diseases. Specifically, 

a falsely low AFP-L3% could result in 

a determination that the patient is at a 

lower risk of developing hepatocellular 

carcinoma, which could delay 

appropriate monitoring and treatment. 

A falsely high AFP-L3% could result in 

a determination that the patient is at a