## 43580 Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Rules and Regulations

[FR Doc. 2011–17974 Filed 7–20–11; 8:45 am]

**BILLING CODE 4910–13–P**



### DEPARTMENT OF TRANSPORTATION

**Federal Aviation Administration**

**14 CFR Part 97**

**[Docket No. 30792; Amdt. No. 3434]**



### Standard Instrument Approach **Procedures, and Takeoff Minimums and Obstacle Departure Procedures;** 
**Miscellaneous Amendments**

**AGENCY** 

### : Federal Aviation Administration (FAA), DOT.

**ACTION** 

### : Final rule.

**SUMMARY** 

### : This 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 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 July 21, 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 July 21,

2011.

**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. Availability —All SIAPs and Takeoff
Minimums and ODPs are available online free of charge. Visit http:// www.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 Divisions, 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 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its
associated Takeoff Minimums or ODP for an identified airport is listed on 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 FAA Forms 8260–3, 8260–4, 8260 –5, 8260–15A, and 8260–15B when required by an entry on 8260–

15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the Federal Register expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. The advantages of incorporation by reference are realized and publication of the complete description of each SIAP,
Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs
and the effective dates of the associated
Takeoff Minimums and ODPs. 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, Takeoff Minimums and
ODP as contained in the transmittal.
Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously 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
Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff
Minimums and ODPS 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 Takeoff Minimums and ODPs, 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, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some 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).


## 43581 Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Rules and Regulations

Issued in Washington, DC, on July 8, 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 establishing, amending, suspending, or revoking Standard Instrument Approach
Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures
effective at 0902 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 28 JUL 2011

Brunswick, ME, Brunswick Executive, RNAV

(GPS) RWY 1R, Orig Brunswick, ME, Brunswick Executive, RNAV

(GPS) RWY 19L, Orig Brunswick, ME, Brunswick Executive,

Takeoff Minimums and Obstacle DP, Orig

Effective 25 AUG 2011

Allakaket, AK, Allakaket, RNAV (GPS) RWY

5, Amdt 1 Allakaket, AK, Allakaket, RNAV (GPS) RWY

23, Amdt 1 Dillingham, AK, Dillingham, RNAV (GPS)

RWY 1, Amdt 2 Dillingham, AK, Dillingham, RNAV (GPS)

RWY 19, Amdt 2 Hooper Bay, AK, Hooper Bay, RNAV (GPS)

RWY 13, Amdt 1 Hooper Bay, AK, Hooper Bay, RNAV (GPS)

RWY 31, Amdt 1 Nuiqsut, AK, Nuiqsut, RNAV (GPS) RWY 5,

Amdt 1 Nuiqsut, AK, Nuiqsut, RNAV (GPS) RWY 23,

Amdt 1 Palmer, AK, Palmer Muni, RNAV (GPS) RWY

9, Amdt 1 Toksook Bay, AK, Toksook Bay, RNAV (GPS)

RWY 34, Amdt 2 Haleyville, AL, Posey Field, GPS RWY 36,

Orig, CANCELLED Haleyville, AL, Posey Field, RNAV (GPS)

RWY 18, Orig Haleyville, AL, Posey Field, RNAV (GPS)

RWY 36, Orig Haleyville, AL, Posey Field, VOR/DME RWY

18, Amdt 5 Haleyville, AL, Posey Field, VOR/DME–A,

Amdt 4 Tuskegee, AL, Moton Field Muni, RNAV

(GPS) RWY 13, Amdt 1 Tuskegee, AL, Moton Field Muni, RNAV

(GPS) RWY 31, Amdt 1 Bullhead City, AZ, Laughln/Bullhead Intl,

RNAV (GPS) RWY 16, Amdt 2 Fort Huachuca Sierra Vista, AZ, Sierra Vista Muni-Libby AAF, RNAV (GPS) RWY 8,
Amdt 1 Tucson, AZ, Marana Rgnl, RNAV (GPS) RWY

12, Amdt 1 Tucson, AZ, Marana Rgnl, RNAV (GPS) RWY

21, Amdt 1 Window Rock, AZ, Window Rock, RNAV

(GPS) RWY 2, Amdt 1 Mojave, CA, Mojave, Takeoff Minimums and

Obstacle DP, Amdt 2 Grand Junction, CO, Grand Junction Rgnl,

RNAV (GPS) Y RWY 11, Amdt 1A Grand Junction, CO, Grand Junction Rgnl,

RNAV (RNP) Z RWY 11, Orig Hayden, CO, Yampa Valley, RNAV (GPS)

RWY 28, Amdt 2 Oxford, CT, Waterbury-Oxford, ILS OR LOC

RWY 36, Amdt 14 Oxford, CT, Waterbury-Oxford, RNAV (GPS)

RWY 36, Amdt 1 Willimantic, CT, Windham, RNAV (GPS)

RWY 9, Amdt 1 Willimantic, CT, Windham, RNAV (GPS)

RWY 27, Amdt 1 Cairo, GA, Cairo-Grady County, NDB RWY

13, Amdt 5 Cairo, GA, Cairo-Grady County, RNAV (GPS)

RWY 13, Amdt 1 Cairo, GA, Cairo-Grady County, RNAV (GPS)

RWY 31, Amdt 1 Douglas, GA, Douglas Muni, ILS OR LOC/

NDB RWY 4, Amdt 2 Douglas, GA, Douglas Muni, RNAV (GPS)

RWY 4, Amdt 1 Douglas, GA, Douglas Muni, RNAV (GPS)

RWY 22, Amdt 1 Hana, HI, Hana, LINDBERG TWO Graphic DP Kailua/Kona, HI, Kona Intl at Keahole,

Takeoff Minimums and Ostacle DP, Amdt

5 Pocahontas, IA, Pocahontas Muni, NDB RWY

12, Amdt 5 Pocahontas, IA, Pocahontas Muni, RNAV

(GPS) RWY 12, Orig Pocahontas, IA, Pocahontas Muni, RNAV

(GPS) RWY 30, Orig Pocahontas, IA, Pocahontas Muni, Takeoff

Minimums & Obstacle DP, Amdt 3 Bedford, IN, Virgil I Grissom Muni, GPS

RWY 13, Orig, CANCELLED Bedford, IN, Virgil I Grissom Muni, GPS

RWY 31, Orig, CANCELLED Bedford, IN, Virgil I Grissom Muni, RNAV

(GPS) RWY 13, Orig Bedford, IN, Virgil I Grissom Muni, RNAV

(GPS) RWY 31, Orig Bedford, IN, Virgil I Grissom Muni, VOR/

DME RWY 31, Amdt 9, CANCELLED Gary, IN, Gary/Chicago Intl, RNAV (GPS) Y

RWY 12, Orig Gary, IN, Gary/Chicago Intl, RNAV (GPS) Y

RWY 30, Orig Tell City, IN, Perry County Muni, NDB OR

GPS RWY 13, Orig, CANCELLED Tell City, IN, Perry County Muni, RNAV

(GPS) RWY 13, Orig Tell City, IN, Perry County Muni, RNAV

(GPS) RWY 31, Orig Tell City, IN, Perry County Muni, Takeoff

Minimums & Obstacle DP, Amdt 2 Tell City, IN, Perry County Muni, VOR OR

GPS RWY 31, Amdt 5, CANCELLED Hazard, KY, Wendell H. Ford, RNAV (GPS)

RWY 14, Amdt 1 Hazard, KY, Wendell H. Ford, RNAV (GPS)

RWY 32, Orig Springfield, KY, Lebanon-Springfield, NDB RWY 11, Orig, CANCELLED Springfield, KY, Lebanon-Springfield, VOR/

DME RWY 11, Amdt 4 Springhill, LA, Springhill, NDB RWY 36,

Orig, CANCELLED Springhill, LA, Springhill, RNAV (GPS) RWY

18, Orig Springhill, LA, Springhill, RNAV (GPS) RWY

36, Orig Springhill, LA, Springhill, Takeoff

Minimums and Obstacle DP, Orig Hyannis, MA, Barnstable Muni-Boardman/

Polando Field, RNAV (GPS) RWY 33, Orig Benton Harbor, MI, Southwest Michigan

Rgnl, LOC BC RWY 9, Amdt 9A,

CANCELLED Benton Harbor, MI, Southwest Michigan

Rgnl, NDB RWY 28, Amdt 10 Benton Harbor, MI, Southwest Michigan

Rgnl, RNAV (GPS) RWY 10, Amdt 1 Benton Harbor, MI, Southwest Michigan

Rgnl, RNAV (GPS) RWY 28, Orig Benton Harbor, MI, Southwest Michigan

Rgnl, Takeoff Minimums and Obstacle DP,
Amdt 7 Benton Harbor, MI, Southwest Michigan

Rgnl, VOR RWY 10, Amdt 10 Benton Harbor, MI, Southwest Michigan

Rgnl, VOR RWY 28, Amdt 19 Holland, MI, Tulip City, RNAV (GPS) RWY

8, Amdt 2 Port Huron, MI, St. Clair County Intl, Takeoff

Minimums and Obstacle DP, Amdt 6 McComb, MS, McComb/Pike County/John E

Lewis Field, RNAV (GPS) RWY 15, Amdt

1 Raymond, MS, John Bell Williams, ILS OR

LOC RWY 12, Orig Raymond, MS, John Bell Williams, NDB

RWY 12, Amdt 2 Raymond, MS, John Bell Williams, RNAV

(GPS) RWY 12, Amdt 2 Raymond, MS, John Bell Williams, RNAV

(GPS) RWY 30, Amdt 2 Raymond, MS, John Bell Williams, Takeoff

Minimums & Obstacle DP, Amdt 4 Bozeman, MT, Gallatin Field, RNAV (GPS)

–A, Amdt 2 Forsyth, MT, Tillitt Field, GPS RWY 26, Orig,

CANCELLED Forsyth, MT, Tillitt Field, RNAV (GPS) RWY

26, Orig, Glendive, MT, Dawson Community, NDB

RWY 12, Amdt 4B Glendive, MT, Dawson Community, RNAV

(GPS) RWY 12, Orig Glendive, MT, Dawson Community, RNAV

(GPS) RWY 30, Orig Glendive, MT, Dawson Community, Takeoff

Minimums & Obstacle DP, Orig Miles City, MT, Frank Wiley Field, RNAV

(GPS) RWY 4, Amdt 2 Miles City, MT, Frank Wiley Field, RNAV

(GPS) RWY 22, Orig Miles City, MT, Frank Wiley Field, VOR/

DME RWY 22, Amdt 8B Hickory, NC, Hickory Rgnl, HICKORY TWO

Graphic DP Roanoke Rapids, NC, Halifax-Northampton

Rgnl, RNAV (GPS) RWY 2, Amdt 1 Roanoke Rapids, NC, Halifax-Northampton

Rgnl, RNAV (GPS) RWY 20, Amdt 1Sanford, NC, Raleigh Exec Jetport at SanfordLee County, ILS OR LOC RWY 3, Amdt 1Sanford, NC, Raleigh Exec Jetport at SanfordLee County, RNAV (GPS) RWY 3, Amdt 1


## 43582 Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Rules and Regulations

Sanford, NC, Raleigh Exec Jetport at SanfordLee County, RNAV (GPS) RWY 21, Amdt

1Sanford, NC, Raleigh Exec Jetport at SanfordLee County, Takeoff Minimums and Obstacle DP, Amdt 1 Rugby, ND, Rugby Muni, GPS RWY 12, Orig,

CANCELLEDRugby, ND, Rugby Muni, GPS RWY 30, OrigB, CANCELLED Rugby, ND, Rugby Muni, RNAV (GPS) RWY

12, Orig Rugby, ND, Rugby Muni, RNAV (GPS) RWY

30, Orig Rugby, ND, Rugby Muni, Takeoff Minimums

and Obstacle DP, Orig Chadron, NE, Chadron Muni, ILS OR LOC

RWY 2, Amdt 2 Chadron, NE, Chadron Muni, RNAV (GPS)

RWY 2, Orig-A Chadron, NE, Chadron Muni, RNAV (GPS)

RWY 11, Orig Chadron, NE, Chadron Muni, RNAV (GPS)

RWY 20, Amdt 1 Chadron, NE, Chadron Muni, RNAV (GPS)

RWY 29, Orig Chadron, NE, Chadron Muni, Takeoff

Minimums and Obstacle DP, Orig Chadron, NE, Chadron Muni, VOR/DME

RWY 2, Amdt 2A, CANCELLED Chadron, NE, Chadron Muni, VOR/DME

RWY 20, Orig-A, CANCELLED Hartington, NE, Hartington Muni, GPS RWY

13, Orig, CANCELLED Hartington, NE, Hartington Muni, GPS RWY

31, Orig, CANCELLED Hartington, NE, Hartington Muni/Bud Becker

Fld, RNAV (GPS) RWY 13, Orig Hartington, NE, Hartington Muni/Bud Becker

Fld, RNAV (GPS) RWY 31, Orig Hartington, NE, Hartington Muni/Bud Becker

Fld, Takeoff Minimums and Obstacle DP, Orig Manville, NJ, Central Jersey Rgnl, RNAV

(GPS) RWY 25, Amdt 1A Morristown, NJ, Morristown Muni, RNAV

(GPS) Z RWY 23, Orig-A Morristown, NJ, Morristown Muni, RNAV

(RNP) Y RWY 23, Orig Albany, NY, Albany Intl, COPTER ILS OR

LOC/DME RWY 1, Amdt 1, CANCELLED Albany, NY, Albany Intl, GPS RWY 10, Orig,

CANCELLEDAlbany, NY, Albany Intl, GPS RWY 28, OrigB, CANCELLED Albany, NY, Albany Intl, ILS OR LOC RWY

1, ILS RWY 1 (SA CAT II), Amdt 11 Albany, NY, Albany Intl, ILS OR LOC RWY

19, Amdt 23 Albany, NY, Albany Intl, RNAV (GPS) RWY

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

28, Orig Albany, NY, Albany Intl, RNAV (GPS) Y

RWY 1, Amdt 1 Albany, NY, Albany Intl, RNAV (GPS) Y

RWY 19, Amdt 1 Albany, NY, Albany Intl, RNAV (RNP) Z

RWY 1, Orig Albany, NY, Albany Intl, RNAV (RNP) Z

RWY 19, Orig Albany, NY, Albany Intl, Takeoff Minimums

and Obstacle DP, Amdt 12 Buffalo, NY, Buffalo Airfield, RNAV (GPS)

RWY 6, Orig Buffalo, NY, Buffalo Airfield, RNAV (GPS)

RWY 24, Amdt 1 New York, NY, La Guardia, ILS OR LOC RWY 22, ILS RWY 22 (SA CAT I), ILS RWY 22 (SA CAT II), Amdt 20 Eugene, OR, Mahlon Sweet Field, RNAV

(GPS) Y RWY 16L, Amdt 2 Eugene, OR, Mahlon Sweet Field, RNAV

(GPS) Y RWY 16R, Amdt 1 Eugene, OR, Mahlon Sweet Field, RNAV

(GPS) Y RWY 34L, Amdt 2 Eugene, OR, Mahlon Sweet Field, RNAV

(GPS) Y RWY 34R, Amdt 2 Eugene, OR, Mahlon Sweet Field, RNAV

(RNP) Z RWY 16L, Orig Eugene, OR, Mahlon Sweet Field, RNAV

(RNP) Z RWY 16R, Orig Eugene, OR, Mahlon Sweet Field, RNAV

(RNP) Z RWY 34L, Orig Eugene, OR, Mahlon Sweet Field, RNAV

(RNP) Z RWY 34R, Orig Redmond, OR, Roberts Field, RNAV (GPS) Y

RWY 4, Orig-A Redmond, OR, Roberts Field, RNAV (GPS) Y

RWY 22, Orig-A Redmond, OR, Roberts Field, RNAV (RNP) Z

RWY 4, Orig Redmond, OR, Roberts Field, RNAV (RNP) Z

RWY 22, Orig Meadville, PA, Port Meadville, RNAV (GPS)

RWY 7, Amdt 1 Meadville, PA, Port Meadville, RNAV (GPS)

RWY 25, Amdt 1 Philadelphia, PA, Philadelphia Intl, ILS OR

LOC RWY 26, Amdt 4 Philadelphia, PA, Philadelphia Intl, ILS PRM

RWY 26 (Sim. Close Parallel), Amdt 4 Philadelphia, PA, Philadelphia Intl, RNAV

(GPS) RWY 26, Amdt 1 Miller, SD, Miller Muni, GPS RWY 15, Orig,

CANCELLED Miller, SD, Miller Muni, GPS RWY 33, Orig,

CANCELLED Miller, SD, Miller Muni, RNAV (GPS) RWY

15, Orig Miller, SD, Miller Muni, RNAV (GPS) RWY

33, Orig Sioux Falls, SD, Joe Foss Field, ILS OR LOC

RWY 21, Amdt 10 Sioux Falls, SD, Joe Foss Field, RNAV (GPS)

RWY 3, Amdt 1 Sioux Falls, SD, Joe Foss Field, RNAV (GPS)

RWY 21, Amdt 1 Alpine, TX, Alpine-Casparis Muni, GPS RWY

19, Orig-A, CANCELLED Alpine, TX, Alpine-Casparis Muni, RNAV

(GPS) RWY 19, Orig Bonham, TX, Jones Field, RNAV (GPS) RWY

17, Amdt 2 Bonham, TX, Jones Field, RNAV (GPS) RWY

35, Amdt 1 Bonham, TX, Jones Field, Takeoff Minimums

and Obstacle DP, Amdt 2 El Paso, TX, El Paso Intl, RNAV (GPS) Y

RWY 22, Orig-C El Paso, TX, El Paso Intl, RNAV (RNP) Z

RWY 22, Orig El Paso, TX, El Paso Intl, Takeoff Minimums

and Obstacle DP, Amdt 6 Fort Worth, TX, Fort Worth Alliance, ILS OR

LOC RWY 34R, Amdt 6 San Antonio, TX, San Antonio Intl, RNAV

(RNP) Z RWY 21, Orig-A Sulphur Springs, TX, Sulphur Springs Muni,

RNAV (GPS) RWY 1, Amdt 1 Sulphur Springs, TX, Sulphur Springs Muni,

RNAV (GPS) RWY 19, Orig Winters, TX, Winters Muni, NDB OR GPS

RWY 35, Orig-A, CANCELLED Winters, TX, Winters Muni, RNAV (GPS) RWY 17, Orig Winters, TX, Winters Muni, RNAV (GPS)

RWY 35, Orig Winters, TX, Winters Muni, Takeoff

Minimums and Obstacle DP, Orig Richland, WA, Richland, VOR RWY 26,

Amdt 7A, CANCELLED Wenatchee, WA, Pangborn Memorial, RNAV

(RNP) RWY 12, Orig-B Sparta, WI, Sparta/Fort McCoy, RNAV (GPS)

RWY 29, Amdt 1 Laramie, WY, Laramie Rgnl, RNAV (GPS)

RWY 3, Orig Laramie, WY, Laramie Rgnl, RNAV (GPS)

RWY 21, Orig

[FR Doc. 2011–17984 Filed 7–20–11; 8:45 am]

**BILLING CODE 4910–13–P**



### DEPARTMENT OF HEALTH AND
**HUMAN SERVICES**

**Food and Drug Administration**

**21 CFR Part 870**

**[Docket No. FDA–2007–N–0092] (Formerly Docket No. 2007N–0308)** 



### Cardiovascular Devices; Classification **of Electrocardiograph Electrodes**

**AGENCY** 

### : Food and Drug Administration,

HHS.

**ACTION** 

### : Final rule.

**SUMMARY** 

### : The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.

**DATES** 

### : This rule is effective August 22,

2011.

**FOR FURTHER INFORMATION CONTACT** 

### : Sharon Lappalainen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1238, Silver Spring,
MD 20993, 301–796–6322.

**SUPPLEMENTARY INFORMATION** 

### :
I. Regulatory Authorities

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et

seq. ), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94–295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101–629), the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105–115), and
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107–250), established a comprehensive system for the regulation