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

CANCELLEDCharlottesville, 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


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

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


### 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 Obsta cle 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, Orig5–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


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

[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 onAugust 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.



### T ABLE 

### 1—H EALTH 

### R ISKS AND 

### M ITIGATIONS

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