Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 15825 

instead of ‘‘* * * updated yearly 

***’’ This technical amendment 

corrects those errors. 

EFFECTIVE DATE: 0901 UTC, April 3, 

2007. The Director of the Federal 

Register approves this incorporation by 

reference action under 1 CFR part 51, 

subject to the annual revision of FAA 

Order 7400.9 and publication of 

conforming amendments. 

FOR FURTHER INFORMATION CONTACT: 

Tameka Bentley, Airspace and Rules, 

Office of System Operations Airspace 

and AIM, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

History 

On July 24, 2006, a final rule was 

published in the Federal Register, 

Docket No. FAA–2005–23157, Airspace 

Docket No. 05–ANM–15 that amended 

Title 14 Code of Federal Regulations 

part 71 by amending Class E Airspace; 

Kalispell, MT (71 FR 41727). In that 

rule, the reference to FAA Order 7400.9 

was published as FAA Order 7400.9O. 

The correct reference is FAA Order 

7400.9P. In addition, the corresponding 

date that refers to the date the Order was 

signed had been omitted. The final rule 

should state ‘‘* * * dated September 1, 

2006 * * *’’ (prior to the effective date), 

instead of ‘‘* * * updated yearly 

***’’

Amendment to Final Rule 

■ Accordingly, pursuant to the authority 

delegated to me, the reference to FAA 

Order 7400.9 for Airspace Docket No. 

FAA–2005–23157, Airspace Docket No. 

05–ANM–15, as published in the 

Federal Register on July 24, 2006 (71 FR 

41727), is corrected as follows: 

■ On page 41727, column 2, (from the 

bottom, counting up) line 3, and column 

3, (from the bottom, counting up) lines 

7, and 9, amend the language to read: 

§ 71.1 [Amended] 

* * * * * 

‘‘FAA Order 7400.9P’’ instead of 

‘‘FAA Order 7400.9O’’

Remove ‘‘* * * updated yearly 

***’’ and insert ‘‘* * * dated 

September 1, 2006 * * *’’

* * * * * 

Issued in Washington, DC, March 23, 2007. 

Edith V. Parish, 

Manager, Airspace and Rules. 

[FR Doc. E7–6098 Filed 4–2–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2005–23361; Airspace 

Docket No. 05–ANM–17] 

RIN 2120–AA66 

Revision of Class E Airspace; 

Pinedale, WY 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: This technical amendment 

corrects a final rule published in the 

Federal Register on July 24, 2006 (71 FR 

41728), Docket No. FAA–2005–23361, 

Airspace Docket No. 05–ANM–17. In 

that rule, the reference to FAA Order 

7400.9 was published as FAA Order 

7400.9O. The correct reference is FAA 

Order 7400.9P. Also, the corresponding 

date that refers to the date the Order was 

signed was omitted. The final rule 

should state ‘‘* * * dated September 1, 

2006 * * *’’ (prior to the effective date), 

instead of ‘‘* * * updated yearly 

***’’. This technical amendment 

corrects those errors. 

EFFECTIVE DATE: 0901 UTC, April 3, 

2007. The Director of the Federal 

Register approves this incorporation by 

reference action under 1 CFR part 51, 

subject to the annual revision of FAA 

Order 7400.9 and publication of 

conforming amendments. 

FOR FURTHER INFORMATION CONTACT: 

Tameka Bentley, Airspace and Rules, 

Office of System Operations Airspace 

and AIM, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

History 

On July 24, 2006, a final rule was 

published in the Federal Register, 

Docket No. FAA–2005–23361, Airspace 

Docket No. 05–ANM–17 that amended 

Title 14 Code of Federal Regulations 

part 71 by revising Class E Airspace; 

Pinedale, WY (71 FR 41728). In that 

rule, the reference to FAA Order 7400.9 

was published as FAA Order 7400.9O. 

The correct reference is FAA Order 

7400.9P. In addition, the corresponding 

date that refers to the date the Order was 

signed had been omitted. The final rule 

should state ‘‘* * * dated September 1, 

2006 * * *’’ (prior to the effective date), 

instead of ‘‘* * * updated yearly 

***’’. 

Amendment to Final Rule 

■ Accordingly, pursuant to the authority 

delegated to me, the reference to FAA 

Order 7400.9 for Airspace Docket No. 

FAA–2005–23361, Airspace Docket No. 

05–ANM–17, as published in the 

Federal Register on July 24, 2006 (71 FR 

41728), is corrected as follows: 

■ On page 41728, column 2, line 13, and 

column 3, lines 5, and 7, amend the 

language to read: 

§ 71.1 [Amended] 

* * * * * 

‘‘FAA Order 7400.9P’’ instead of 

‘‘FAA Order 7400.9O’’

Remove ‘‘* * * updated yearly 

***’’ and insert ‘‘* * * dated 

September 1, 2006 * * *’’

* * * * * 

Issued in Washington, DC, March 23, 2007. 

Edith V. Parish, 

Manager, Airspace and Rules. 

[FR Doc. E7–6100 Filed 4–2–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30543 Amdt. No. 3212] 

Standard Instrument Approach 

Procedures, Weather Takeoff 

Minimums; Miscellaneous 

Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This amendment establishes, 

amends, suspends, or revokes Standard 

Instrument Approach Procedures 

(SIAPs) and/or Weather Takeoff 

Minimums for operations at certain 

airports. These regulatory actions are 

needed because of the adoption of new 

or revised criteria, or 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 April 3, 

2007. The compliance date for each 

SIAP and/or Weather Takeoff 

Minimums is specified in the 

amendatory provisions. 

The incorporation by reference of 

certain publications listed in the 


rwilkins on PROD1PC63 with RULES
15826 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 

regulations is approved by the Director 

of the Federal Register as of April 3, 

2007. 

ADDRESSES: Availability of matters 

incorporated by reference in the 

amendment is as follows: 

For Examination—1. FAA Rules 

Docket, FAA Headquarters Building, 

800 Independence Avenue, SW., 

Washington, DC 20591; 

2. The FAA Regional Office of the 

region in which the affected airport is 

located; 

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 and 

Weather Takeoff Minimums 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 

and Weather Takeoff Minimums 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 of the Code of 

Federal Regulations, Part 97 (14 CFR 

part 97), establishes, amends, suspends, 

or revokes SIAPs and/or Weather 

Takeoff Minimums. The complete 

regulatory description of each SIAP 

and/or Weather Takeoff Minimums is 

contained in official FAA form 

documents which are incorporated by 

reference in this amendment under 5 

U.S.C. 552(a), 1 CFR part 51, and 14 

CFR part 97.20. The applicable FAA 

Forms are identified as FAA Forms 

8260–3, 8260–4, 8260–5 and 8260–15A. 

Materials incorporated by reference are 

available for examination or purchase as 

stated above. 

The large number of SIAPs and/or 

Weather Takeoff Minimums, 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 and/or Weather Takeoff 

Minimums but refer to their 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 and/ 

or Weather Takeoff Minimums 

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 and/or Weather 

Takeoff Minimums. 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 and/or Weather Takeoff 

Minimums as contained in the 

transmittal. Some SIAP and/or Weather 

Takeoff Minimums amendments may 

have been previously issued by the FAA 

in a Flight Data Center (FDC) Notice to 

Airmen (NOTAM) as an emergency 

action of immediate flight safety relating 

directly to published aeronautical 

charts. The circumstances which 

created the need for some SIAP, and/or 

Weather Takeoff Minimums 

amendments may require making them 

effective in less than 30 days. For the 

remaining SIAPs and/or Weather 

Takeoff Minimums, an effective date at 

least 30 days after publication is 

provided. 

Further, the SIAPs and/or Weather 

Takeoff Minimums contained in this 

amendment are based on the criteria 

contained in the U.S. Standard for 

Terminal Instrument Procedures 

(TERPS). In developing these SIAPs 

and/or Weather Takeoff Minimums, the 

TERPS criteria were applied to the 

conditions existing or anticipated at the 

affected airports. Because of the close 

and immediate relationship between 

these SIAPs and/or Weather Takeoff 

Minimums and safety in air commerce, 

I find that notice and public procedure 

before adopting these SIAPs and/or 

Weather Takeoff Minimums are 

impracticable and contrary to the public 

interest and, where applicable, that 

good cause exists for making some 

SIAPs and/or Weather Takeoff 

Minimums 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 March 23, 

2007. 

James J. Ballough, 

Director, Flight Standards Service. 

Adoption of the Amendment 

■ Accordingly, pursuant to the authority 

delegated to me, under Title 14, Code of 

Federal Regulations, Part 97 (14 CFR 

part 97) is amended by establishing, 

amending, suspending, or revoking 

Standard Instrument Approach 

Procedures and Weather Takeoff 

Minimums 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: 

Effective 10 May 2007 

Bessemer, AL, Bessemer, ILS OR LOC RWY 

5, Amdt 1 

Bessemer, AL, Bessemer, RNAV (GPS) RWY 

5, Orig 

Bessemer, AL, Bessemer, GPS RWY 5, Orig, 

CANCELLED 

Bessemer, AL, Bessemer, Takeoff Minimums 

and Obstacle DP, Orig 

Huntsville, AL, Madison County Executive, 

ILS OR LOC/DME RWY 18, Orig 

Fort Yukon, AK, Fort Yukon, RNAV (GPS) 

RWY 4, Orig 

Fort Yukon, AK, Fort Yukon, RNAV (GPS) 

RWY 22, Orig 


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Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 15827 

Fort Yukon, AK, Fort Yukon, GPS RWY 3, 

Orig, CANCELLED 

Fort Yukon, AK, Fort Yukon, GPS RWY 21, 

Orig, CANCELLED 

Fort Yukon, AK, Fort Yukon, VOR/DME OR 

TACAN–A, Orig 

Fort Yukon, AK, Fort Yukon, VOR/DME OR 

TACAN RWY 3, Amdt 1C, CANCELLED 

Fort Yukon, AK, Fort Yukon, VOR/DME OR 

TACAN RWY 22, Amdt 2 

Fort Yukon, AK, Fort Yukon, VOR RWY 3, 

Amdt 4B, CANCELLED 

Fort Yukon, AK, Fort Yukon, VOR RWY 21, 

Amdt 4A, CANCELLED 

Fort Yukon, AK, Fort Yukon, Takeoff 

Minimums and Obstacle DP, Amdt 1 

Hemet, CA, Hemet-Ryan, NDB–A, Amdt 1A, 

CANCELLED 

Marysville, CA, Yuba County, VOR RWY 32, 

Amdt 10D, CANCELLED 

Colorado Springs, CO, City of Colorado 

Springs Muni, RNAV (GPS) RWY 17R, 

Amdt 1A 

Middletown, DE, Summit, RNAV (GPS) RWY 

17, Amdt 1 

Middletown, DE, Summit, RNAV (GPS) RWY 

35, Orig 

Middletown, DE, Summit, GPS RWY 35, 

ORIG–A, CANCELLED 

Jacksonville, FL, Jacksonville Intl, VOR/DME 

RWY 31, Amdt 1 

Jacksonville, FL, Jacksonville Intl, Takeoff 

Minimums and Textual DP, Orig 

Miami, FL, Miami Intl, RNAV (GPS) RWY 8L, 

Amdt 1 

Miami, FL, Miami Intl, RNAV (GPS) RWY 

26R, Amdt 1 

West Palm Beach, FL, Palm Beach Intl, 

RNAV (GPS) RWY 31, Amdt 1 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

ILS OR LOC RWY 10, Amdt 1, ILS RWY 

10 (CAT II), ILS RWY 10 (CAT III) 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

ILS OR LOC RWY 28, Amdt 1, ILS RWY 

28 (CAT II) 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

ILS PRM RWY 10, Amdt 1, ILS PRM RWY 

10 (CAT II), ILS PRM RWY 10 (CAT III) 

(SIMULTANEOUS CLOSE PARALLEL) 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

ILS PRM RWY 28, Amdt 1, ILS PRM RWY 

28 (CAT II) (SIMULTANEOUS CLOSE 

PARALLEL) 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 9L, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 8L, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 8R, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 9R, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 10, Amdt 1 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 26L, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 26R, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 27L, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 27R, Amdt 2 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (GPS) Y RWY 28, Amdt 1 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 8L, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 8R, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 9L, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 9R, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 10, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 26L, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 26R, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 27L, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 27R, Orig 

Atlanta, GA, Hartsfield-Jackson Atlanta Intl, 

RNAV (RNP) Z RWY 28, Orig Brunswick, 

GA, Brunswick Golden Isles, ILS OR LOC 

RWY 7, Amdt 9 

Freeport, IL, Albertus, RNAV (GPS) RWY 24, 

Orig 

Freeport, IL, Albertus, VOR RWY 24, Amdt 

7 

Freeport, IL, Albertus, Takeoff Minimums 

and Textual DP, Orig 

Seymour, IN, Freeman Muni, RNAV (GPS) 

RWY 14, Orig 

Seymour, IN, Freeman Muni, RNAV (GPS) 

RWY 23, Amdt 1 

Seymour, IN, Freeman Muni, RNAV (GPS) 

RWY 32, Orig 

Seymour, IN, Freeman Muni, RNAV (GPS) 

RWY 5, Orig 

Seymour, IN, Freeman Muni, NDB RWY 5, 

Amdt 4 

Seymour, IN, Freeman Muni, LOC/NDB RWY 

5, Orig 

Seymour, IN, Freeman Muni, LOC RWY 5, 

Amdt 3, CANCELLED 

Seymour, IN, Freeman Muni, Takeoff 

Minimums and Textual DP, Orig 

Shelbyville, IN, Shelbyville Muni, RNAV 

(GPS) RWY 1, Amdt 1 

Shelbyville, IN, Shelbyville Muni, RNAV 

(GPS) RWY 19, Amdt 1 

Middlesboro, KY, Middlesboro-Bell County, 

RNAV (GPS)–A, Orig 

Williamsburg, KY, Williamsburg-Whitley 

County, RNAV (GPS) RWY 2, Orig 

Williamsburg, KY, Williamsburg-Whitley 

County, RNAV (GPS) RWY 20, Orig 

Williamsburg, KY, Williamsburg-Whitley 

County, Takeoff Minimums and Textual 

DP, Orig 

Belfast, ME, Belfast Muni, RNAV (GPS) RWY 

15, Orig 

Belfast, ME, Belfast Muni, RNAV (GPS) RWY 

33, Orig 

Belfast, ME, Belfast Muni, Takeoff Minimums 

and Textual DP, Amdt 2 

Belfast, ME, Belfast Muni, GPS RWY 15, 

Amdt 1, CANCELLED 

Belfast, ME, Belfast Muni, GPS RWY 33, 

Amdt 1, CANCELLED 

Holland, MI, Tulip City, Takeoff Minimums 

and Textual DP, Orig 

Holland, MI, Tulip City, ILS OR LOC/DME 

RWY 26, Amdt 1 

Holland, MI, Tulip City, RNAV (GPS) RWY 

26, Amdt 2 

Holland, MI, Tulip City, RNAV (GPS) RWY 

8, Amdt 1 

Minneapolis, MN, Minneapolis-St Paul Intl/ 

Wold-Chamberlain, Takeoff Minimums 

and Obstacle DP, Amdt 11 

Oxford, MS, University-Oxford, RNAV (GPS) 

RWY 9, Orig 

Oxford, MS, University-Oxford, RNAV (GPS) 

RWY 27, Orig 

Oxford, MS, University-Oxford, GPS RWY 9, 

Orig, CANCELLED 

Oxford, MS, University-Oxford, GPS RWY 

27, Orig, CANCELLED 

Albany, NY, Albany Intl, RNAV (GPS) RWY 

1, Orig 

Albany, NY, Albany Intl, RNAV (GPS) RWY 

19, Orig 

Albany, NY, Albany Intl, GPS RWY 1, OrigB, CANCELLED 

Albany, NY, Albany Intl, GPS RWY 19, OrigB, CANCELLED 

Elmira, NY, Elmira/Corning Rgnl, Takeoff 

Minimums and Textual DP, Amdt 8 

Penn Yan, NY, Penn Yan, RNAV (GPS) RWY 

1, Amdt 2 

Plattsburgh, NY, Plattsburgh Intl, ILS or LOC/ 

DME RWY 35, Orig 

Mocksville, NC, Twin Lakes, RNAV (GPS) 

RWY 9, Orig 

Mocksville, NC, Twin Lakes, NDB OR GPS 

RWY 9, Amdt 5, CANCELLED 

Columbus, OH, Port Columbus Intl, ILS OR 

LOC RWY 10L, Amdt 18 

Columbus, OH, Port Columbus Intl, ILS OR 

LOC RWY 28L, Amdt 28 

Columbus, OH, Port Columbus Intl, ILS OR 

LOC RWY 28R, Amdt 3 

Columbus, OH, Port Columbus Intl, RNAV 

(GPS) RWY 10L, Amdt 1 

Columbus, OH, Port Columbus Intl, RNAV 

(GPS) RWY 28L, Amdt 1 

Columbus, OH, Port Columbus Intl, RNAV 

(GPS) RWY 10R, Amdt 1 

Columbus, OH, Port Columbus Intl, Takeoff 

Minimums and Obstacle DP, Amdt 6 

Ottawa, OH, Putnam County, NDB RWY 27, 

Amdt 1B, CANCELLED 

North Bend, OR, Southwest Oregon Regional, 

COPTER ILS OR LOC RWY 4, Orig 

The Dalles, OR, Columbia Gorge Regional/ 

The Dalles Muni, LDA/DME RWY 25, Orig 

The Dalles, OR, Columbia Gorge Regional/ 

The Dalles Muni, COPTER LDA/DME RWY 

25, Orig 

Greer, SC, Greenville-Spartanburg Intl-Roger 

Milliken, RNAV (GPS) RWY 4, Amdt 1 

Greer, SC, Greenville-Spartanburg Intl-Roger 

Milliken, RNAV (GPS) RWY 22, Amdt 1 

Rapid City, SD, Rapid City Regional, Takeoff 

Minimums and Obstacle DP, Amdt 6 

Elizabethton, TN, Elizabethton Muni, RNAV 

(GPS) RWY 6, Orig 

Jacksboro, TN, Campbell County, Takeoff 

Minimums and Obstacle DP, Amdt 2 

Roanoke, VA, Roanoke Regional/Woodrum 

Field, ILS OR LOC RWY 33, Amdt 12 

Moses Lake, WA, Grant County Intl, ILS OR 

LOC RWY 32R, Amdt 20 

Moses Lake, WA, Grant County Intl, Takeoff 

Minimums and Obstacle DP, Orig 

Spokane, WA, Felts Field, Takeoff 

Minimums and Textual DP, Amdt 4 

Spokane, WA, Spokane Intl, ILS OR LOC 

RWY 3, Amdt 5, ILS RWY 3 (CAT II), ILS 

RWY 3 (CAT III) 

Spokane, WA, Spokane Intl, ILS OR LOC/ 

DME RWY 21, Amdt 21, ILS RWY 21 (CAT 

II), ILS RWY 21 (CAT III) 

Ashland, WI, John F. Kennedy Memorial, 

LOC/DME RWY 2, Orig 

Ashland, WI, John F. Kennedy Memorial, 

Takeoff Minimums and Textual DP, Orig 

Eagle River, WI, Eagle River Union, LOC/ 

DME RWY 4, Orig 


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15828 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 

Juneau, WI, Dodge County, RNAV (GPS) 

RWY 2, Orig 

Juneau, WI, Dodge County, RNAV (GPS) 

RWY 8, Orig 

Juneau, WI, Dodge County, RNAV (GPS) 

RWY 20, Orig 

Juneau, WI, Dodge County, RNAV (GPS) 

RWY 26, Orig 

Juneau, WI, Dodge County, NDB RWY 2, Orig 

Juneau, WI, Dodge County, NDB RWY 20, 

Orig 

Juneau, WI, Dodge County, LOC RWY 26, 

Amdt 1 

Juneau, WI, Dodge County, GPS RWY 20, 

Orig, CANCELLED 

Juneau, WI, Dodge County, NDB RWY 2, 

Amdt 10A, CANCELLED 

Juneau, WI, Dodge County, NDB RWY 20, 

Amdt 8A, CANCELLED 

Lone Rock, WI, Tri-County Regional, VOR/ 

DME RNAV OR GPS RWY 27, Amdt 6, 

CANCELLED 

[FR Doc. E7–5952 Filed 4–2–07; 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–0471] 

Microbiology Devices; Reclassification 

of Herpes Simplex Virus Types 1 and 

2 Serological Assays 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reclassifying 

herpes simplex virus (HSV) types 1 and/ 

or 2 (HSV 1 and 2) serological assays 

from class III (premarket approval) to 

class II (special controls). FDA had 

earlier proposed this reclassification on 

its own initiative based on new 

information. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing the availability of a class II 

special controls guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Herpes Simplex Virus Types 

1 and 2 Serological Assays.’’

DATES: This rule is effective May 3, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Sally Hojvat, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0496. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 

(SMDA) (Public Law 101–629), the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA) (Public Law 105–

115), and the Medical Device User Fee 

and Modernization Act (Public Law 

107–250), established a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513 of the act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, defined by the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under the 1976 amendments, class II 

devices were defined as devices for 

which there was insufficient 

information to show that general 

controls themselves would provide 

reasonable assurance of safety and 

effectiveness, but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. SMDA broadened the 

definition of class II devices to mean 

those devices for which the general 

controls by themselves are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but for which 

there is sufficient information to 

establish special controls to provide 

such assurance, including performance 

standards, postmarket surveillance, 

patient registries, development and 

dissemination of guidelines, 

recommendations, and any other 

appropriate actions the agency deems 

necessary (section 513(a)(1)(B) of the 

act). 

Under section 513 of the act, FDA 

refers to devices that were in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as preamendments 

devices. FDA classifies these devices 

after it takes the following steps: (1) 

Receives a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) publishes the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) publishes 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. A person may market a 

preamendments device that has been 

classified into class III through 

premarket notification procedures, 

without submission of a premarket 

approval application (PMA), until FDA 

issues a final regulation under section 

515(b) of the act (21 U.S.C. 360e(b)) 

requiring premarket approval. 

Devices that were not in commercial 

distribution before May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f) of the act) into 

class III without any FDA rulemaking 

process. Those devices remain in class 

III and require premarket approval 

unless and until FDA does the 

following: (1) Reclassifies the device 

into class I or II; (2) issues an order 

classifying the device into class I or II 

in accordance with section 513(f)(2) of 

the act, as amended by FDAMA; or (3) 

issues an order finding the device to be 

substantially equivalent, under section 

513(i) of the act, to a legally marketed 

device that has been classified into class 

I or class II. The agency determines 

whether new devices are substantially 

equivalent to a legally marketed device 

by means of premarket notification 

procedures in section 510(k) of the act 

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

Section 513(e) of the act governs 

reclassification of classified devices. 

This section provides that FDA may, by 

rulemaking, reclassify a device based 

upon ‘‘new information.’’ FDA can 

initiate a reclassification under section 

513(e) of the act or an interested person 

may petition FDA to reclassify a 

preamendments device. The term ‘‘new 

information,’’ as used in section 513(e) 

of the act, includes information 

developed as a result of a reevaluation 

of the data before the agency when the 

device was originally classified, as well 

as information not presented, not 

available, or not developed at that time 

(see, e.g., Holland Rantos v. United 

States Department of Health, Education, 

and Welfare, 587 F.2d 1173, 1174 n.1 

(D.C. Cir. 1978); Upjohn v. Finch, 422 

F.2d 944 (6th Cir. 1970);Bell v. Goddard, 

366 F.2d 177 (7th Cir. 1966)). 

Reevaluation of the data previously 

before the agency is an appropriate basis 

for subsequent regulatory action where 

the reevaluation is made in light of 

newly available regulatory authority 

(see Bell v. Goddard, supra, 366 F.2d at 

181; Ethicon, Inc. v.FDA, 762 F.Supp. 

382, 389–91 (D.D.C. 1991)), or in light 

of changes in ‘‘medical science’’ (see 

Upjohn v. Finch, supra, 422 F.2d at 

951). Whether data before the agency are 

past or new, the ‘‘new information’’ to 

support reclassification under section 

513(e) of the act must be ‘‘valid 

scientific evidence,’’ as defined in 

section 513(a)(3) of the act and 21 CFR 


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