21234 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Rules and Regulations 

Hallock, MN, Hallock Muni, RNAV (GPS) 

RWY 31, Orig 

Hallock, MN, Hallock Muni, Takeoff 

Minimums and Obstacle DP, Orig 

Little Falls, MN, Little Falls/Morrison 

County-Lindbergh Fld, GPS RWY 31, OrigA, CANCELLED 

Little Falls, MN, Little Falls/Morrison 

County-Lindbergh Fld, RNAV (GPS) RWY 

31, Orig 

Marshall, MN, Southwest Minnesota Rgnl/ 

Marshall/Ryan Fld, GPS RWY 30, Orig-A, 

CANCELLED 

Marshall, MN, Southwest Minnesota Rgnl/ 

Marshall/Ryan Fld, RNAV (GPS) RWY 30, 

Orig 

St Paul, MN, Lake Elmo, NDB RWY 4, Amdt 

5 

St Paul, MN, Lake Elmo, RNAV (GPS) RWY 

32, Amdt 1 

Moberly, MO, Omar N Bradley, VOR/DME 

RNAV OR GPS RWY 13, Amdt 1, 

CANCELLED 

Moberly, MO, Omar N Bradley, VOR/DME 

RNAV OR GPS RWY 31, Amdt 1, 

CANCELLED 

Clarksdale, MS, Fletcher Field, RNAV (GPS) 

RWY 18, Amdt 1 

Clarksdale, MS, Fletcher Field, RNAV (GPS) 

RWY 36, Amdt 1 

Tunica, MS, Tunica Muni, ILS or LOC/DME 

RWY 35, Amdt 1 

Tunica, MS, Tunica Muni, RNAV (GPS) RWY 

17, Amdt 3 

Tunica, MS, Tunica Muni, RNAV (GPS) RWY 

35, Amdt 2 

Tunica, MS, Tunica Muni, VOR/DME–A, 

Orig 

Bismarck, ND, Bismarck Muni, ILS OR LOC 

RWY 13, Amdt 3 

Bismarck, ND, Bismarck Muni, ILS OR LOC 

RWY 31, Amdt 33 

Bismarck, ND, Bismarck Muni, RNAV (GPS) 

RWY 3, Amdt 2 

Bismarck, ND, Bismarck Muni, RNAV (GPS) 

RWY 13, Orig 

Bismarck, ND, Bismarck Muni, RNAV (GPS) 

RWY 21, Amdt 1 

Bismarck, ND, Bismarck Muni, RNAV (GPS) 

RWY 31, Amdt 1 

Bismarck, ND, Bismarck Muni, VOR–A, 

Amdt 21 

Walhalla, ND, Walhalla Muni, Takeoff 

Minimums and Obstacle DP, Orig 

Creighton, NE, Creighton Muni, RNAV (GPS) 

RWY 13, Orig 

Creighton, NE, Creighton Muni, RNAV (GPS) 

RWY 31, Orig 

Creighton, NE, Creighton Muni, Takeoff 

Minimums and Obstacle DP, Orig 

Lincoln, NE, Lincoln, VOR RWY 17, Amdt 7 

Lincoln, NE, Lincoln, VOR RWY 18, Amdt 13 

Nashua, NH, Boire Field, RNAV (GPS) RWY 

32, Orig-A 

Poughkeepsie, NY, Dutchess County, ILS OR 

LOC RWY 6, Amdt 6A 

Poughkeepsie, NY, Dutchess County, RNAV 

(GPS) RWY 6, Orig-A 

Poughkeepsie, NY, Dutchess County, VOR/ 

DME RWY 6, Amdt 6A 

Watertown, NY, Watertown Intl, ILS OR LOC 

RWY 7, Amdt 7 

Watertown, NY, Watertown Intl, RNAV (GPS) 

RWY 7, Amdt 2 

Watertown, NY, Watertown Intl, VOR RWY 

7, Amdt 14 

White Plains, NY, Westchester County, ILS 

OR LOC RWY 16, Amdt 23A 

Cadiz, OH, Harrison County, GPS RWY 13, 

Orig, CANCELLED 

Cadiz, OH, Harrison County, GPS RWY 31, 

Orig, CANCELLED 

Cadiz, OH, Harrison County, RNAV (GPS) 

RWY 13, Orig 

Cadiz, OH, Harrison County, RNAV (GPS) 

RWY 31, Orig 

Cadiz, OH, Harrison County, Takeoff 

Minimums and Obstacle DP, Amdt 3 

Cleveland, OH, Cleveland-Hopkins Intl, 

CONVERGING ILS RWY 24R, Amdt 1 

Cleveland, OH, Cleveland-Hopkins Intl, ILS 

OR LOC RWY 6R, ILS RWY 6R (SA CAT 

II), Amdt 21 

Cleveland, OH, Cleveland-Hopkins Intl, ILS 

OR LOC RWY 24L, ILS RWY 24L (SA CAT 

II), Amdt 22 

Cleveland, OH, Cleveland-Hopkins Intl, ILS 

OR LOC/DME RWY 24R, ILS RWY 24R 

(CAT II), ILS RWY 24R (CAT III), ILS RWY 

24R (SA CAT I), Amdt 5 

Cleveland, OH, Cleveland-Hopkins Intl, ILS 

PRM RWY 24R (Simultaneous Close 

Parallel), Amdt 1 

Cleveland, OH, Cleveland-Hopkins Intl, 

RNAV (GPS) RWY 24L, Amdt 3 

Cleveland, OH, Cleveland-Hopkins Intl, 

RNAV (GPS) RWY 24R, Amdt 3 

Oklahoma City, OK, Wiley Post, ILS OR LOC 

RWY 35R, Orig 

Scappoose, OR, Scappoose Industrial 

Airpark, RNAV (GPS) RWY 15, Orig 

Scappoose, OR, Scappoose Industrial 

Airpark, VOR/DME–A, Amdt 3 

St. George, SC, St George, VOR/DME–A, 

Amdt 2, CANCELLED 

Dyersburg, TN, Dyersburg Rgnl, Takeoff 

Minimums and Obstacle DP, Amdt 1 

Gallatin, TN, Summer County Rgnl, Takeoff 

Minimums and Obstacle DP, Amdt 3 

Charlottesville, VA, CharlottesvilleAlbemarle, ILS OR LOC RWY 3, Amdt 14, 

CANCELLED 

Charlottesville, VA, CharlottesvilleAlbemarle, ILS OR LOC RWY 3, Orig 

Burlington, VT, Burlington Intl, RNAV (GPS) 

RWY 33, Orig, CANCELLED 

Burlington, VT, Burlington Intl, RNAV (GPS) 

Y RWY 33, Orig 

Burlington, VT, Burlington Intl, RNAV (GPS) 

Z RWY 33, Orig 

Amery, WI, Amery Muni, NDB RWY 18, 

Amdt 6A, CANCELLED 

Madison, WI, Dane County Rgnl-Traux Field, 

RNAV (GPS) RWY 14, Amdt 2 

Madison, WI, Dane County Rgnl-Traux Field, 

RNAV (GPS) RWY 32, Amdt 2 

Madison, WI, Dane County Rgnl-Traux Field, 

Takeoff Minimums and Obstacle DP, Amdt 

8 

Madison, WI, Dane County Rgnl-Traux Field, 

VOR RWY 18, Amdt 1 

Madison, WI, Dane County Rgnl-Traux Field, 

VOR RWY 32, Amdt 1 

Middleton, WI, Middleton Muni-Morey 

Field, VOR RWY 10, Amdt 1 

Mosinee, WI, Central Wisconsin, ILS OR LOC 

RWY 8, Amdt 13 

Mosinee, WI, Central Wisconsin, ILS OR LOC 

RWY 35, Amdt 2 

Mosinee, WI, Central Wisconsin, RNAV 

(GPS) RWY 8, Amdt 1 

Mosinee, WI, Central Wisconsin, RNAV 

(GPS) RWY 17, Amdt 1 

Mosinee, WI, Central Wisconsin, RNAV 

(GPS) RWY 26, Amdt 1 

Mosinee, WI, Central Wisconsin, RNAV 

(GPS) RWY 35, Amdt 1 

Mosinee, WI, Central Wisconsin, VOR/DME 

RWY 35, Amdt 9 

Waupaca, WI, Waupaca Muni, RNAV (GPS) 

RWY 10, Amdt 1 

Waupaca, WI, Waupaca Muni, RNAV (GPS) 

RWY 28, Amdt 1 

On March 4, 2011 (76 FR 11944) the FAA 

published an Amendment in Docket No. 

30770, Amdt 3414 to Part 97 of the Federal 

Aviation Regulations under section 97.33. 

The following entries, published in TL 11– 

07 effective for 05 MAY 2011, are hereby 

rescinded: 

Hartford, CT, Hartford-Brainard, LDA RWY 2, 

Amdt 1G 

Hartford, CT, Hartford-Brainard, VOR OR 

GPS–A, Amdt 9C 

On March 25, 2011 (76 FR 16690) the FAA 

published an Amendment in Docket No. 

30772, Amdt 3416 to Part 97 of the Federal 

Aviation Regulations under section 97.33. 

The following entry, published in TL 11–08 

effective for 05 MAY 2011, is hereby 

rescinded: 

Kamuela, HI, Waimea-Kohala, RNAV (GPS) 

RWY 4, Amdt 1 

On March 25, 2011 (76 FR 16691) the FAA 

published an Amendment in Docket No. 

30772, Amdt 3416 to Part 97 of the Federal 

Aviation Regulations under section 97.33. 

The following entries, published in TL 11– 

08 effective for 05 MAY 2011, are hereby 

rescinded: 

Kamuela, HI, Waimea-Kohala, VOR/DME 

RWY 4, Amdt 1 

Niles, MI, Jerry Tyler Memorial, VOR OR 

GPS RWY 3, Amdt 7A, CANCELLED 

Niles, MI, Jerry Tyler Memorial, VOR OR 

GPS RWY 21, Amdt 3A,CANCELLED 

[FR Doc. 2011–8934 Filed 4–14–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30777; Amdt. No. 3421] 

Standard Instrument Approach 

Procedures, and Takeoff Minimums 

and Obstacle Departure Procedures; 

Miscellaneous Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This rule establishes, amends, 

suspends, or revokes Standard 

Instrument Approach Procedures 

(SIAPs) and associated Takeoff 

Minimums and Obstacle Departure 

Procedures for operations at certain 

airports. These regulatory actions are 

needed because of the adoption of new 

or revised criteria, or because of changes 


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Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Rules and Regulations 21235 

occurring in the National Airspace 

System, such as the commissioning of 

new navigational facilities, adding new 

obstacles, or changing 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 15, 

2011. The compliance date for each 

SIAP, associated Takeoff Minimums, 

and ODP 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 April 15, 

2011. 

ADDRESSES: Availability of matter 

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. 

Availability—All SIAPs are available 

online free of charge. Visit http:// 

nfdc.faa.gov to register. Additionally, 

individual SIAP and Takeoff Minimums 

and ODP 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. 

FOR FURTHER INFORMATION CONTACT: 

Harry J. Hodges, 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 rule 

amends Title 14, Code of Federal 

Regulations, Part 97 (14 CFR part 97) by 

amending the referenced SIAPs. The 

complete regulatory description of each 

SIAP is listed on the appropriate FAA 

Form 8260, as modified by the National 

Flight Data Center (FDC)/Permanent 

Notice to Airmen (P–NOTAM), and is 

incorporated by reference in the 

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

CFR part 51, and § 97.20 of Title 14 of 

the Code of Federal Regulations. 

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. This 

amendment provides the affected CFR 

sections and specifies the types of SIAP 

and the corresponding effective dates. 

This amendment also identifies the 

airport and its location, the procedure 

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 changes to 

SIAPs, the TERPS criteria were applied 

only to 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. 

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 April 1, 

2011. 

John M. Allen, 

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, MLS, MLS/DME, MLS/RNAV; 

§ 97.31 RADAR SIAPs; § 97.33 RNAV 

SIAPs; and § 97.35 COPTER SIAPs, 

Identified as follows: 

* * * Effective Upon Publication 


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21236 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Rules and Regulations 

AIRAC 

date State City Airport FDC No. FDC date Subject 

5–May–11 NE Lincoln ...................... Lincoln ........................................ 1/0794 3/23/11 ILS OR LOC RWY 18, Amdt 6F 

5–May–11 FL Venice ....................... Venice Muni ............................... 1/1934 3/23/11 Takeoff Minimums and Obstacle

DP, Amdt 2 

5–May–11 NC Greenville ................. Pitt-Greenville ............................. 1/2023 3/23/11 RNAV (GPS) RWY 2, Orig 

5–May–11 NY Niagara Falls ............ Niagara Falls Intl ........................ 1/2456 3/23/11 NDB OR GPS RWY 28R, Amdt 

16A 

5–May–11 NC Greenville ................. Pitt-Greenville ............................. 1/2789 3/23/11 ILS OR LOC RWY 20, Amdt 4 

5–May–11 TX Dallas ........................ Dallas Love Field ....................... 1/3002 3/23/11 RNAV (GPS) Z RWY 13L, Orig-B 

5–May–11 VA Orange ...................... Orange County ........................... 1/5119 3/4/11 VOR/DME OR GPS A, Amdt 2A 

5–May–11 GA Rome ........................ Richard B Russell ...................... 1/5120 3/4/11 ILS/DME RWY 1, Orig-A 

5–May–11 NJ Linden ....................... Linden ........................................ 1/5393 3/7/11 Takeoff Minimums and Obstacle 

DP, Amdt 2 

5–May–11 NJ Newark ..................... Newark Liberty Intl ..................... 1/5735 3/4/11 RNAV (RNP) Z RWY 29, Orig-A 

5–May–11 MD Cambridge ................ Cambridge-Dorchester ............... 1/6177 3/1/11 NDB OR GPS RWY 34, Amdt 7 

5–May–11 FL Deland ...................... Deland Muni-Sidney H Taylor 

Field.

1/6474 3/1/11 RNAV (GPS) RWY 5, Orig 

5–May–11 FL Panama City ............. Northwest Florida Beaches Intl .. 1/6475 3/1/11 RNAV (GPS) RWY 16, Orig-B 

5–May–11 FL Panama City ............. Northwest Florida Beaches Intl .. 1/6476 3/1/11 RNAV (GPS) RWY 34, Orig-B 

5–May–11 WV Charleston ................ Yeager ........................................ 1/6478 3/1/11 Takeoff Minimums and Obstacle

DP, Amdt 8 

5–May–11 RI Providence ................ Theodore Francis Green State .. 1/6567 3/1/11 ILS RWY 34, Amdt 10B 

5–May–11 NJ Newark ..................... Newark Liberty Intl ..................... 1/6957 3/4/11 RNAV (RNP) Y RWY 29, Orig-A 

5–May–11 CT Groton (New London) Groton-New London ................... 1/7378 3/7/11 ILS OR LOC RWY 5, Amdt 11B 

5–May–11 VT Morrisville ................. Morrisville-Stowe State .............. 1/7381 3/9/11 NDB OR GPS B, Amdt 1C 

5–May–11 VT Morrisville ................. Morrisville-Stowe State .............. 1/7382 3/9/11 Takeoff Minimums and Obstacle 

DP, Amdt 2 

5–May–11 MS Starkville ................... George M Bryan ........................ 1/7383 3/14/11 LOC/DME RWY 36, Orig 

5–May–11 FL Lakeland ................... Lakeland Linder Rgnl ................. 1/7480 3/7/11 RNAV (GPS) RWY 27, Orig 

5–May–11 NY White Plains ............. Westchester County ................... 1/7527 3/7/11 RNAV (RNP) Z RWY 34, Orig 

5–May–11 MA Falmouth ................... Cape Cod Coast Guard Air Station.1/7535 3/7/11 ILS OR LOC RWY 32, Orig 

5–May–11 KY Lexington .................. Blue Grass ................................. 1/7821 3/1/11 ILS OR LOC RWY 22, Amdt 20 

5–May–11 AL Auburn ...................... Auburn University Rgnl .............. 1/7887 3/7/11 RNAV (GPS) RWY 18, Orig 

5–May–11 AL Auburn ...................... Auburn University Rgnl .............. 1/7888 3/7/11 RNAV (GPS) RWY 11, Orig 

5–May–11 NY Poughkeepsie ........... Dutchess County ........................ 1/8102 3/9/11 Takeoff Minimums and Obstacle 

DP, Amdt 1 

5–May–11 TN Memphis ................... Memphis Intl ............................... 1/8162 3/7/11 RNAV (RNP) Y RWY 18R, Orig 

5–May–11 TN Memphis ................... Memphis Intl ............................... 1/8163 3/7/11 RNAV (RNP) X RWY 18L, Orig 

5–May–11 TN Memphis ................... Memphis Intl ............................... 1/8164 3/7/11 RNAV (RNP) Y RWY 18L, Orig 

5–May–11 PA Perkasie .................... Pennridge ................................... 1/8350 3/7/11 Takeoff Minimums and Obstacle

DP, Orig 

5–May–11 DC Washington ............... Washington Dulles Intl ............... 1/8351 3/7/11 RNAV (GPS) RWY 12, Amdt 1 

5–May–11 DC Washington ............... Washington Dulles Intl ............... 1/8353 3/7/11 RNAV (GPS) RWY 1L, Orig 

5–May–11 WI Madison .................... Blackhawk Airfield ...................... 1/8455 3/9/11 VOR OR GPS A, Orig-C 

5–May–11 AL Lanett ........................ Lanett Muni ................................ 1/8471 3/7/11 VOR/DME OR GPS A, Amdt 2A 

5–May–11 IA Keokuk ...................... Keokuk Muni .............................. 1/8893 3/9/11 RNAV (GPS) RWY 14, Orig 

5–May–11 IA Keokuk ...................... Keokuk Muni .............................. 1/8894 3/9/11 ILS OR LOC/DME RWY 26, Orig 

5–May–11 IA Keokuk ...................... Keokuk Muni .............................. 1/8895 3/9/11 RNAV (GPS) RWY 26, Orig 

5–May–11 IA Keokuk ...................... Keokuk Muni .............................. 1/8896 3/9/11 RNAV (GPS) RWY 8, Orig 

5–May–11 NC Goldsboro ................. Goldsboro-Wayne Muni ............. 1/9054 3/7/11 VOR A, Amdt 5 

5–May–11 NC Goldsboro ................. Goldsboro-Wayne Muni ............. 1/9055 3/7/11 RNAV (GPS) RWY 23, Orig 

5–May–11 NC Goldsboro ................. Goldsboro-Wayne Muni ............. 1/9056 3/7/11 ILS OR LOC RWY 23, Amdt 1A 

5–May–11 NY Middletown ............... Randall ....................................... 1/9081 3/4/11 NDB RWY 26, Amdt 1 

5–May–11 VA Marion/Wytheville ..... Mouintain Empire ....................... 1/9082 3/4/11 RNAV (GPS) RWY 26, Orig 

5–May–11 WV Ravenswood ............. Jackson County ......................... 1/9088 3/4/11 Takeoff Minimums and Obstacle 

DP, Amdt 1 

5–May–11 KS Concordia ................. Blosser Muni .............................. 1/9097 3/9/11 GPS RWY 17, Orig-A 

5–May–11 IL Morris ........................ Morris Muni-James R. 

Washburn.

1/9221 3/4/11 RNAV (GPS) RWY 18, Orig 

5–May–11 VA Martinsville ................ Blue Ridge ................................. 1/9234 3/4/11 LOC RWY 30, Amdt 1 

5–May–11 NE Lincoln ...................... Lincoln ........................................ 1/9352 3/23/11 ILS OR LOC RWY 36, Amdt 11E 

5–May–11 IL Peru .......................... Illinois Valley Rgnl-Walter A 

Cuncan Field.

1/9358 3/9/11 LOC RWY 36, Amdt 3A 

5–May–11 IL Peru .......................... Illinois Valley Rgnl-Walter A 

Cuncan Field.

1/9360 3/9/11 RNAV (GPS) RWY 18, Orig-A 

5–May–11 IL Peru .......................... Illinois Valley Rgnl-Walter A 

Cuncan Field.

1/9362 3/9/11 RNAV (GPS) RWY 36, Orig-A 

5–May–11 NY New York .................. La Guardia ................................. 1/9829 3/9/11 RNAV (RNP) Z RWY 22, Orig 

5–May–11 NY Poughkeepsie ........... Dutchess County ........................ 1/9964 3/23/11 VOR A, Amdt 11 

5–May–11 NY Poughkeepsie ........... Dutchess County ........................ 1/9965 3/23/11 RNAV (GPS) RWY 24, Orig 

5–May–11 NY Poughkeepsie ........... Dutchess County ........................ 1/9966 3/23/11 VOR/DME RWY 24, Amdt 4A 


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Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Rules and Regulations 21237 

[FR Doc. 2011–8930 Filed 4–14–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 884 

[Docket No. FDA–2011–N–0118] 

Medical Devices; Obstetrical and 

Gynecological Devices; Classification 

of the Hemorrhoid Prevention Pressure 

Wedge 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

hemorrhoid prevention pressure wedge 

into class II (special controls). The 

special controls will apply to the device 

in order to provide a reasonable 

assurance of safety and effectiveness of 

the device. A hemorrhoid prevention 

pressure wedge provides support to the 

perianal region during the labor and 

delivery process. 

DATES: This rule is effective May 16, 

2011. The classification was applicable 

on January 13, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Glenn Bell, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. G112, Silver Spring, 

MD 20993–0002, 301–796–6531. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

the Federal Food, Drug, and Cosmetic 

Act (the FD&C 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), 

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 FD&C Act (21 

U.S.C.360c(i)), 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 FD&C Act (21 

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

807) of the regulations. 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA will, within 60 

days of receiving this request, classify 

the device by written order. This 

classification will 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 this classification. 

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

the FD&C Act, FDA issued an order on 

August 5, 2009, classifying the HemAvert Perianal Stabilizer into 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 which was subsequently 

reclassified into class I or class II. On 

August 17, 2009, Plexus Biomedical, 

Inc., submitted a petition requesting 

classification of the Hem-Avert Perianal 

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

FD&C Act. The manufacturer 

recommended that the device be 

classified into class II. (Ref. 1) 

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

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices 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 device 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 hemorrhoid prevention pressure 

wedge, and it is identified as a 

hemorrhoid prevention pressure wedge 

that provides mechanical support to the 

perianal region during the labor and 

delivery process. External mechanical 

support of the perianal region is 

intended to help prevent the occurrence 

of external hemorrhoids associated with 

vaginal childbirth. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the 

recommended measures to mitigate 

these risks. 

TABLE 1—HEALTH RISKS AND MITIGATIONS

Identified risk Mitigation measures 

Skin/tissue trauma (e.g., rectal and/or anal trauma, necrosis, thinning, abrasion, laceration to the perineum, vulvar hematoma, sloughing).Nonclinical Analysis and Testing. 

Clinical Information. 

Labeling. 

Device failure (e.g., material failure, slippage) ................................................................................................. Nonclinical Analysis and Testing. 

Labeling. 

Device failure—obstruction to the treatment area caused by inability to remove the instrument quickly ....... Device Description.

Labeling. 

Infection. ............................................................................................................................................................ Labeling. 

Adverse tissue reaction ..................................................................................................................................... Biocompatibility. 

Pain ................................................................................................................................................................... Nonclinical Analysis and Testing. 

Biocompatibility. 

FDA believes that the following 

special controls address the risks to 

health and provide reasonable assurance 

of the safety and effectiveness of the 

device: (1) The sale, distribution, and 

use of this device are restricted to 


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