69274 Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 

Greenwood, MS, Greenwood-LeFlore, VOR/ 

DME RNAV RWY 18, Amdt 6A 

Wahpeton, ND, Harry Stern, RNAV (GPS) 

RWY 15, Orig 

Wahpeton, ND, Harry Stern, RNAV (GPS) 

RWY 33, Orig 

Wahpeton, ND, Harry Stern, NDB RWY 33, 

Amdt 5 

Wahpeton, ND, Harry Stern, GPS RWY 33, 

Orig-A, CANCELLED 

Grand Island, NE, Central Nebraska Regional, 

RNAV (GPS) RWY 13, Amdt 1 

Grand Island, NE, Central Nebraska Regional, 

RNAV (GPS) RWY 17, Amdt1 

Grand Island, NE, Central Nebraska Regional, 

RNAV (GPS) RWY 31, Amdt1 

Grand Island, NE, Central Nebraska Regional, 

RNAV (GPS) RWY 35, Amdt1 

Hobbs, NM, Lea County Rgnl, RNAV (GPS) 

RWY 3, Orig 

Hobbs, NM, Lea County Rgnl RNAV (GPS) 

RWY 21, Orig 

Hobbs, NM, Lea County Rgnl RNAV (GPS) 

RWY 30, Orig 

Hobbs, NM, Lea County Rgnl ILS OR LOC 

RWY 3, Amdt 6 

Hobbs, NM, Lea County Rgnl LOC/DME BC 

RWY 21, Amdt 6 

Hobbs, NM, Lea County Rgnl VOR/DME OR 

TACAN RWY 21, Amdt 9 

Hobbs, NM, Lea County Rgnl VOR OR 

TACAN RWY 3, Amdt 21 

Hobbs, NM, Lea County Rgnl GPS RWY 3, 

Orig-B, CANCELLED 

Hobbs, NM, Lea County Rgnl GPS RWY 21, 

Orig-B, CANCELLED 

Hobbs, NM, Lea County Rgnl GPS RWY 30, 

Orig-B, CANCELLED 

Las Vegas, NV, Henderson Executive, VOR–

C, Orig 

Las Vegas, NV, North Las Vegas, ILS OR LOC 

RWY 12L, Orig 

Fort Worth, TX, Fort Worth Spinks, RNAV 

(GPS) RWY 17R, Orig 

Fort Worth, TX, Fort Worth Spinks, RNAV 

(GPS) RWY 35L, Orig 

Fort Worth, TX, Fort Worth Spinks, VOR/ 

DME RNAV RWY 35L, Orig-B, 

CANCELLED 

Houston, TX, George Bush Intercontinental/ 

Houston, RNAV (GPS) Z RWY 8L, Amdt 1 

Houston, TX, George Bush Intercontinental/ 

Houston, RNAV (GPS) Z RWY 9, Amdt 2 

Houston, TX, George Bush Intercontinental/ 

Houston, RNAV (GPS) Z RWY 27, Amdt 1 

Houston, TX, George Bush Intercontinental/ 

Houston, RNAV (GPS) Z RWY 26R, Amdt 

1 

Houston, TX, George Bush Intercontinental/ 

Houston, ILS OR LOC RWY 8L, ILS RWY 

8L, (CAT II), ILS RWY 8L (CAT III), Amdt 

1 

Houston, TX, George Bush Intercontinental/ 

Houston, ILS OR LOC RWY 9, Amdt 7 

Houston, TX, George Bush Intercontinental/ 

Houston, ILS OR LOC RWY 27, ILS RWY 

27, (CAT II), ILS RWY 27 (CAT III), Amdt 

6 

Houston, TX, George Bush Intercontinental/ 

Houston, ILS OR LOC RWY 26R, ILS RWY 

26R, (CAT II), ILS RWY 26R (CAT III), 

Amdt 1 

Longview, TX, East Texas Regional, ILS OR 

LOC RWY 13, Amdt 12 

Longview, TX, East Texas Regional, VOR/ 

DME OR TACAN RWY 31, Amdt 7 

Longview, TX, East Texas Regional, VOR/ 

DME OR TACAN RWY 13, Amdt 1 

Wichita Falls, TX, Kickapoo Downtown 

Airpark, RNAV (GPS) RWY 35, Orig 

Wichita Falls, TX, Kickapoo Downtown 

Airpark, NDB RWY 35, Amdt 4 

Wichita Falls, TX, Kickapoo Downtown 

Airpark, NDB–A, Amdt 6A 

Wichita Falls, TX, Kickapoo Downtown 

Airpark, VOR/DME RNAV OR GPS RWY 

35, Amdt 3A, CANCELLED 

Sutton, WV, Braxton County, RNAV (GPS) 

RWY 1, Orig 

Sutton, WV, Braxton County, RNAV (GPS) 

RWY 19, Orig 

Sutton, WV, Braxton County, Takeoff 

Minimums and Textual DP, Orig 

[FR Doc. 05–22494 Filed 11–14–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30465; Amdt. No. 3141] 

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 November 

15, 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 

of the Federal Register as of November 

15, 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 modifiedby 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 

Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 69275 

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 November 4, 

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: 

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 No. 

10/21/05 .... AK IGIUGIG ................. IGIUGIG .................................................. 5/9658 RNAV (GPS) RWY 5, ORIG-A. 

10/21/05 .... AK IGIUGIG ................. IGIUGIG .................................................. 5/9659 RNAV (GPS) RWY 23, ORIG-A. 

10/21/05 .... AK KING SALMON ...... KING SALMON ....................................... 5/9660 RNAV (GPS) Z RWY 29, ORIG-A. 

10/21/05 .... AK KING SALMON ...... KING SALMON ....................................... 5/9661 RNAV (GPS) RWY 11, ORIG-A. 

10/21/05 .... AK SHUNGNAK ........... SHUNGNAK ............................................ 5/9662 RNAV (GPS) RWY 9, ORIG-A. 

10/24/05 .... WA BELLINGHAM ........ BELLINGHAM INTL ................................ 5/9652 ILS RWY 16, AMDT 4B. 

10/24/05 .... WA BELLINGHAM ........ BELLINGHAM INTL ................................ 5/9653 NDB RWY 16, AMDT 1B. 

10/25/05 .... MN MINNEAPOLIS ....... MINNEAPOLIS-ST. PAUL INTL/WOLD 

CHAMBERLAIN.

5/9764 ILS PRM RWY 12R, AMDT 3A. 

10/26/05 .... IL QUINCY ................. QUNICY REGIONAL-BALDWIN FIELD 5/9835 ILS OR LOC RWY 4, AMDT 17A. 

10/28/05 .... MN MINNEAPOLIS ....... MINNEAPOLIS-ST. PAUL INTL/WOLD 

CHAMBERLAIN.

5/9978 ILS PRM RWY 30R, AMDT 6B. 

10/28/05 .... MN MINNEAPOLIS ....... MINNEAPOLIS-ST. PAUL INTL/WOLD 

CHAMBERLAIN.

5/9979 ILS PRM RWY 30L, AMDT 5B. 

10/31/05 .... FL BUNNELL ............... FLAGLER COUNTY ............................... 5/9990 RNAV (GPS) RWY 29, ORIG-A. 

10/31/05 .... IL CHICAGO ............... CHICAGO-O’HARE INTL ........................ 5/0115 ILS RWY 27L (CATII), AMDT 13A. 

10/31/05 .... IL CHICAGO ............... CHICAGO-O’HARE INTL ........................ 5/0116 ILS RWY 27L (CATIII), AMDT 13A. 

10/31/05 .... IL CHICAGO ............... CHICAGO-O’HARE INTL ........................ 5/0117 ILS OR LOC RWY 27L, AMDT 13A. 

10/28/05 .... FL MELBOURNE ......... MELBOURNE INTL ................................ 5/0032 RNAV (GPS) RWY 9R, ORIG-A. 

10/28/05 .... FL BUNNELL ............... FLAGLER COUNTY ............................... 5/9988 VOR-A, AMDT 1A. 

10/28/05 .... FL BUNNELL ............... FLAGLER COUNTY ............................... 5/9989 RNAV (GPS) RWY 6, ORIG-A. 

10/28/05 .... FL BUNNELL ............... FLAGLER COUNTY ............................... 5/9991 RNAV (GPS) RWY 11, ORIG-A. 

10/28/05 .... FL BUNNELL ............... FLAGLER COUNTY ............................... 5/9992 RNAV (GPS) RWY 24, ORIG-A. 

10/28/05 .... FL ORLANDO .............. ORLANDO INTL ..................................... 5/9993 RNAV (GPS) RWY 36R, ORIG-B. 

10/24/05 .... UT LOGAN ................... LOGAN-CACHE ...................................... 5/9717 RNAV (GPS) RWY 17, ORIG-A. 

10/24/05 .... UT LOGAN ................... LOGAN-CACHE ...................................... 5/9720 RNAV (GPS) RWY 35, AMDT 1A. 

10/31/05 .... UT OGDEN .................. ODGEN-HINCKLEY ................................ 5/9940 VOR RWY 7, AMDT 5C. 

10/28/05 .... WA SEATTLE ............... SEATTLE-TACOMA INTL ....................... 5/0133 VOR RWY 34L/R, AMDT 9B. 

10/28/05 .... WA MOSES LAKE ........ GRANT COUNTY INTL .......................... 5/0136 VOR RWY 32R, AMDT 20A. 

10/28/05 .... WA MOSES LAKE ........ GRANT COUNTY INTL .......................... 5/0138 RNAV (GPS) RWY 32R, ORIG-B. 

69276 Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 

FDC Date State City Airport FDC No. Subject No. 

11/01/05 .... OH MARYSVILLE ......... UNION COUNTY .................................... 5/0174 NDB RWY 27, AMDT 5B. 

11/01/05 .... WA YAKIMA .................. YAKIMA AIR TERMINAL/MCALLISTER 

FIELD.

5/0181 ILS RWY 27, AMDT 26C. 

11/01/05 .... WA PORT ANGELES ... WILLIAM R. FAIRCHILD INTL ............... 5/0187 ILS–1 RWY 8, AMDT 1C. 

11/02/05 .... MN ALEXANDRIA ......... CHANDLER FIELD ................................. 5/0218 ILS OR LOC RWY 31, ORIG-A. 

10/27/05 .... TX AUSTIN .................. AUSTIN-BERGSTROM INTL .................. 5/9947 ILS OR LOC RWY 35L, AMDT 3A. 

11/02/05 .... OK ARDMORE ............. ARDMORE MUNI ................................... 5/0226 ILS RWY 31, AMDT 4A. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0232 ILS OR LOC RWY 36, AMDT 1C. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0233 RNAV (GPS) RWY 36, AMDT 1A. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0234 RADAR–1, AMDT 1C. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0235 ILS OR LOC RWY 18, AMDT 1F. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0236 RNAV (GPS) RWY 18, 1C. 

[FR Doc. 05–22493 Filed 11–14–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 25 

[Docket No. 2004N–0461] 

Environmental Assessment; 

Categorical Exclusions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulation on environmental impact 

considerations to expand existing 

categorical exclusions to include 

approvals of humanitarian device 

exemptions (HDEs) and establishment of 

special controls as categories of actions 

that do not individually or cumulatively 

have a significant effect on the human 

environment and for which neither an 

environmental assessment (EA) nor an 

environmental impact statement (EIS) is 

required. FDA is taking this action in 

accordance with the National 

Environmental Policy Act (NEPA). 

DATES: This rule is effective December 

15, 2005. 

FOR FURTHER INFORMATION CONTACT: Rosa 

M. Gilmore, Center for Devices and 

Radiological Health (HFZ–215), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276–

2346. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In the Federal Register of November 

24, 2004 (69 FR 68280), FDA published 

a proposed rule (the November 2004 

proposed rule) to amend its regulation 

on environmental impact considerations 

to expand existing categorical 

exclusions to include approvals of HDEs 

and establishment of special controls as 

categories of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment and for which neither an 

EA nor an EIS is required. Interested 

persons were given until December 27, 

2004, to comment on the proposal. FDA 

received two comments on the proposed 

rule. 

II. Summary of Comments and FDA’s 

Response 

(Comment 1) One comment opposed 

FDA’s proposal to expand existing 

categorical exclusions to include 

approvals of HDEs and establishment of 

special controls on the basis that a more 

rigorous standard should be applied 

before approval of ‘‘dangerous devices.’’

(Response) This comment seemed to 

misunderstand the proposed rule. FDA 

is not excluding any products from the 

statutorily required safety review under 

the Federal Food, Drug, and Cosmetic 

Act. The rule excludes certain categories 

of actions from the need to prepare an 

EA or EIS under the NEPA. 

(Comment 2) This comment did not 

express an opinion on the proposed 

rule. 

III. Background and Regulatory 

Authorities 

NEPA requires all Federal agencies to 

assess the environmental impacts of its 

actions and to ensure that the interested 

and affected public is informed of 

environmental analyses. The Counsel on 

Environmental Quality (CEQ) is 

responsible for overseeing Federal 

efforts to comply with NEPA. Both CEQ 

and FDA have issued regulations 

governing agency obligations and 

responsibilities under NEPA. CEQ’s 

regulations implementing the 

procedural requirements of NEPA can 

be found at 40 CFR parts 1500 through 

1508 and FDA’s NEPA policies and 

procedures can be found at 21 CFR part 

25. 

CEQ’s and FDA’s regulations, 40 CFR 

1508.4 and 21 CFR 25.5(a)(1), 

respectively, define ‘‘categorical 

exclusion’’ to mean a category of actions 

which have been found by procedures 

adopted by the Federal agency not to 

individually or cumulatively have a 

significant effect on the human 

environment and for which, therefore, 

neither an EA nor an EIS is required. 

When categorically excluding an action, 

an agency must determine that there are 

no extraordinary circumstances related 

to the action that may result in the 

action having significant environmental 

effects. 

FDA published final regulations 

governing compliance with NEPA as 

implemented by the CEQ regulations in 

the Federal Register of July 29, 1997 (62 

FR 40570). The July 29, 1997, final rule 

listed certain device actions as 

categories of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment and for which neither an 

EA nor an EIS is required. 

IV. Summary of the Final Rule 

FDA received two comments on the 

proposed rule, however, neither 

comment related to the statutory and 

regulatory authority of that proposal. 

Therefore, the discussion of the 

statutory and regulatory authority set 

out in the preamble of the proposed rule 

(69 FR 68280 at 68281 through 68282) 

remains relevant to this final rule and 

will not be repeated here. 

A. Special Controls 

FDA is amending its environmental 

impact regulations under § 25.34 to 

include as a category of action that does 

not individually or cumulatively have a 

significant effect on the human 

environment and for which neither an 

EA nor EIS is required, classification or 

reclassification of a device, including 

the establishment of special controls, if 

the action will not result in increases in 

the existing levels of use of the device 

or changes in the intended use of the 

device or its substitutes. FDA issues 

special controls in order to assure that 

class II devices provide a reasonable 

assurance of safety and effectiveness.