Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Rules and Regulations 45925 

Lago Vista, TX, Lago Vista TX—Rusty Allen, 

RNAV (GPS) RWY 15, Orig 

Robstown, TX, Nueces County, GPS RWY 13, 

Orig-C, CANCELED 

Robstown, TX, Nueces County, RNAV (GPS) 

RWY 13, Orig 

Robstown, TX, Nueces County, Takeoff 

Minimums and Obstacle DP, Amdt 1 

Clarksville, VA, Lake Country Regional, 

VOR/DME–A, Orig-A, CANCELED 

Richland, WA, Richland, LOC RWY 19, 

Amdt 8 

Richland, WA, Richland, RNAV (GPS) Y 

RWY 19, Amdt 1 

Richland, WA, Richland, RNAV (GPS) Z 

RWY 19, Orig 

Wenatchee, WA, Pangborn Memorial, ILS X 

RWY 12, Orig 

Yakima, WA, Yakima Air Terminal/ 

McAllister Field, RNAV (GPS) X RWY 27, 

Amdt 1A 

Medford, WI, Taylor County, RNAV (GPS) 

RWY 16, Orig 

Medford, WI, Taylor County, RNAV (GPS) 

RWY 34, Orig 

Mineral Point, WI, Iowa County, NDB RWY 

22, Amdt 6 

Mineral Point, WI, Iowa County, RNAV (GPS) 

RWY 4, Amdt 1 

Mineral Point, WI, Iowa County, RNAV (GPS) 

RWY 11, Amdt 1 

Mineral Point, WI, Iowa County, RNAV (GPS) 

RWY 22, Amdt 1 

Mineral Point, WI, Iowa County, RNAV (GPS) 

RWY 29, Amdt 1 

Superior, WI, Richard I Bong, GPS RWY 3, 

Orig, CANCELED 

Superior, WI, Richard I Bong, GPS RWY 13, 

Orig, CANCELED 

Superior, WI, Richard I Bong, GPS RWY 31, 

Orig, CANCELED 

Superior, WI, Richard I Bong, RNAV (GPS) 

RWY 4, Orig 

Superior, WI, Richard I Bong, RNAV (GPS) 

RWY 14, Orig 

Superior, WI, Richard I Bong, RNAV (GPS) 

RWY 22, Orig 

Superior, WI, Richard I Bong, RNAV (GPS) 

RWY 32, Orig 

Casper, WY, Casper/Natrona County Intl, 

Takeoff Minimums and Obstacle DP, Amdt 

4 

Cheyenne, WY, Cheyenne Rgnl/Jerry Olson 

Field, Takeoff Minimums and Obstacle DP, 

Amdt 4 

[FR Doc. 2012–18521 Filed 8–1–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30854; Amdt. No. 3489] 

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 

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 August 2, 

2012. 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 August 2, 

2012. 

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 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: 

Richard A. Dunham III, 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 


sroberts on DSK5SPTVN1PROD with RULES
45926 Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Rules and Regulations 

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 July 20, 

2012. 

John Duncan, 

Deputy 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. 

§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 

97.35 [Amended] 

■ 2. Part 97 is amended to read as 

follows: 

By amending: § 97.23 VOR, VOR/ 

DME, VOR or TACAN, and VOR/DME 

or TACAN; § 97.25 LOC, LOC/DME, 

LDA, LDA/DME, SDF, SDF/DME; 

§ 97.27 NDB, NDB/DME; § 97.29 ILS, 

ILS/DME, MLS, MLS/DME, MLS/RNAV; 

§ 97.31 RADAR SIAPs; § 97.33 RNAV 

SIAPs; and § 97.35 COPTER SIAPs, 

Identified as follows: 

Effective Upon Publication 

AIRAC Date State City Airport FDC No. FDC Date Subject 

23-Aug-12 .... KS Wichita .................... Wichita Mid-Continent ............. 2/0134 7/11/12 RNAV (GPS) RWY 1R, Amdt 1. 

23-Aug-12 .... NE North Platte ............. North Platte Rgnl Airport Lee 

Bird Field.

2/0484 7/11/12 ILS OR LOC RWY 30, Amdt 6. 

23-Aug-12 .... NE North Platte ............. North Platte Rgnl Airport Lee 

Bird Field.

2/0485 7/11/12 VOR RWY 35, Amdt 18A. 

23-Aug-12 .... TX Dallas ...................... Dallas Love Field .................... 2/0613 7/11/12 ILS RWY 13R, Amdt 4D. 

23-Aug-12 .... TX Dallas ...................... Dallas Love Field .................... 2/0617 7/11/12 ILS RWY 13L, Amdt 31B. 

23-Aug-12 .... CA Santa Ana ............... John Wayne Airport-Orange 

County.

2/1446 7/11/12 RNAV (GPS) Y RWY 19R, Amdt 

1B. 

23-Aug-12 .... KS Hutchinson .............. Hutchinson Muni ..................... 2/3180 7/11/12 RNAV (GPS) RWY 31, Amdt 1. 

23-Aug-12 .... MA Orange .................... Orange Muni ........................... 2/3482 7/11/12 VOR A, Amdt 7. 

23-Aug-12 .... MA Worcester ............... Worcester Rgnl ....................... 2/3525 7/11/12 ILS OR LOC RWY 29, Amdt 4. 

23-Aug-12 .... IA Des Moines ............. Des Moines Intl ....................... 2/3637 7/11/12 ILS OR LOC RWY 13, Amdt 9A. 

23-Aug-12 .... OK Tulsa ....................... Tulsa Intl .................................. 2/3664 7/11/12 RNAV (RNP) Z RWY 26, Orig-A. 

23-Aug-12 .... OK Tulsa ....................... Tulsa Intl .................................. 2/3666 7/11/12 RNAV (GPS) Y RWY 26, Amdt 

3. 

23-Aug-12 .... NC Jacksonville ............ Albert J Ellis ............................ 2/4274 7/11/12 RNAV (GPS) RWY 5, Amdt 1. 

23-Aug-12 .... MN Luverne ................... Quentin Aanenson Field ......... 2/5558 7/11/12 RNAV (GPS) RWY 36, Orig. 

23-Aug-12 .... OK Tulsa ....................... Tulsa Intl .................................. 2/6222 7/11/12 VOR OR TACAN RWY 26, Amdt 

24. 

23-Aug-12 .... AL Huntsville ................ Huntsville Intl-Carl T Jones 

Field.

2/6348 7/11/12 ILS OR LOC RWY 18R, Amdt 

24C. 

23-Aug-12 .... TX George West .......... Live Oak County ..................... 2/7921 7/11/12 RNAV (GPS) RWY 13, Orig. 

23-Aug-12 .... TX George West .......... Live Oak County ..................... 2/7922 7/11/12 VOR/DME A, Amdt 2. 

23-Aug-12 .... MN Owatonna ............... Owatonna Degner Rgnl .......... 2/7931 7/11/12 ILS OR LOC RWY 30, Amdt 2A. 

23-Aug-12 .... WI Boyceville ................ Boyceville Muni ....................... 2/7936 7/11/12 RNAV (GPS) RWY 26, Amdt 1. 

23-Aug-12 .... WI Boyceville ................ Boyceville Muni ....................... 2/7937 7/11/12 RNAV (GPS) RWY 8, Amdt 1. 

23-Aug-12 .... MO Mountain Grove ...... Mountain Grove Memorial ....... 2/7942 7/11/12 VOR/DME OR GPS Rwy 8, OrigA. 

23-Aug-12 .... MI Fremont .................. Fremont Muni .......................... 2/8257 7/11/12 RNAV (GPS) RWY 18, Amdt 1B. 

23-Aug-12 .... NY Williamson/Sodus ... Williamson-Sodus .................... 2/8598 7/11/12 RNAV (GPS) RWY 10, Amdt 1. 

23-Aug-12 .... NY Williamson/Sodus ... Williamson-Sodus .................... 2/8599 7/11/12 RNAV (GPS) RWY 28, Amdt 2. 

23-Aug-12 .... FL Miami ...................... Miami Intl ................................. 2/8600 7/11/12 ILS OR LOC RWY 26L, Amdt 

15B. 

23-Aug-12 .... LA New Orleans ........... Louis Armstrong New Orleans 

Intl.

2/8632 7/11/12 ILS OR LOC RWY 1, Amdt 17. 

23-Aug-12 .... CA Santa Ana ............... John Wayne Airport-Orange 

County.

2/8703 7/11/12 ILS OR LOC RWY 19R, Amdt 

12A. 

23-Aug-12 .... TX Austin ...................... Lakeway Airpark ...................... 2/8777 7/11/12 RNAV (GPS) RWY 16, Orig. 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Rules and Regulations 45927 

[FR Doc. 2012–18516 Filed 8–1–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 774 

The Commerce Control List 

CFR Correction 

In Title 15 of the Code of Federal 

Regulations, Parts 300 to 799, revised as 

of January 1, 2012, in supplement no. 1 

to part 774, in Category 6, make the 

following corrections: 

■ 1. In 6A001: 

■ A. On page 807, in the note following 

paragraph 6A001.a.1, add ‘‘equipment 

as follows’’ after ‘‘6A001.a.1 does not 

control’’. 

■ B. On page 807, in paragraph a.1.a.1.a, 

remove ‘‘20’’ and add ‘‘20°’’ in its place. 

■ C. On page 810, designating the notes 

following 6A001.b.2 as ‘‘Note 1’’ and 

‘‘Note 2’’. 

■ D. On page 810, removing the note to 

6A001.a.2 following the N.B. at the end 

of the section. 

■ 2. In 6A992, on page 826, in the table 

for ‘‘License Requirements’’, remove the 

entry for RS and place it below the table 

as an indented paragraph. 

■ 3. In 6B108, on page 830, remove 

‘‘Unit: r’’ and add ‘‘Unit: Number’’ in its 

place. 

■ 4. In 6C005, on page 831, add 

‘‘License Requirements’’ above ‘‘Reason 

for Control’’. 

■ 5. In 6D001, on page 831, remove 

‘‘CIV: * * *’’ and add ‘‘CIV: N/A’’ in its 

place. 

■ 6. In 6D003: 

■ A. On page 832, in ‘‘Reason for 

Control’’, after ‘‘NS’’, add ‘‘RS,’’. 

■ B. On page 833, remove paragraphs 

h.1.a and h.1.b. 

■ 7. In 6E001, on page 834, add 

‘‘License Requirements’’ above ‘‘Reason 

for Control’’. 

■ 8. In 6E002, on page 835, add 

‘‘License Requirements’’ above ‘‘Reason 

for Control’’. 

[FR Doc. 2012–18967 Filed 8–1–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 807 

[Docket No. FDA–2009–N–0114] 

RIN 0910–AF88 

Implementation of Device Registration 

and Listing Requirements Enacted in 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002, the Medical 

Device User Fee and Modernization 

Act of 2002, and Title II of the Food and 

Drug Administration Amendments Act 

of 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to reflect recent statutory 

amendments to the device registration 

and listing provisions of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA), enacted on September 

27, 2007, amended the FD&C Act by 

requiring domestic and foreign device 

establishments to begin submitting their 

registration and device listing 

information to FDA by electronic means 

rather than on paper forms, and also 

specified the timeframes when 

establishments are required to submit 

such information. In addition, this final 

rule would facilitate FDA’s collection of 

additional registration information from 

foreign establishments as required by 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (Bioterrorism 

Act). The final rule will update certain 

provisions in the regulations to improve 

the quality of registration and listing 

information available to FDA. FDA 

relies on having complete and accurate 

registration and listing information in 

order to accomplish a number of 

important public health objectives. 

DATES: This final rule is effective 

October 1, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Ann Ferriter, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 2680, 

Silver Spring, MD 20993–0002, 301– 

796–5686; and 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Overview of the Final Rule 

III. Comments on the Proposed Rule 

IV. Legal Authority 

V. Analysis of Economic Impacts 

VI. Paperwork Reduction Act of 1995 

VII. Environmental Impact 

VIII. Federalism 

IX. References 

I. Background 

We originally published 

establishment registration regulations 

for medical devices in the Federal 

Register of September 3, 1976 (41 FR 

37458) (proposed rule) and August 23, 

1977 (42 FR 42520) (final rule), and 

device listing regulations in the Federal 

Register of September 30, 1977 (42 FR 

52808) (proposed rule), and August 25, 

1978 (43 FR 37990) (final rule). 

These regulations called for 

establishment registration and device 

listing information to be submitted to 

the Center for Devices and Radiological 

Health (CDRH) on several paper forms: 

FDA 2891, Registration of Device 

Establishment; FDA 2891a, Annual 

Registration of Device Establishment; 

and FDA 2892, Device Listing. Once 

these forms were completed and 

submitted to FDA, FDA then forwarded 

them to a data entry contractor who 

entered the information into FDA’s 

device registration and listing database. 

In June 2002, section 321 of the 

Bioterrorism Act (Pub. L. 107–188) 

amended section 510(i) of the FD&C Act 

(21 U.S.C. 360(i)) to require those 

foreign establishments who are required 

to register with FDA to do so by 

electronic means, and to include 

additional information identifying 

certain parties involved in the 

importation of the foreign 

establishment’s devices into the United 

States as part of their registration. 

Subsequently, in October 2002, section 

207 of the Medical Device User Fee and 

Modernization Act (MDUFMA) (Pub. L. 

107–250) further amended section 510 

of the FD&C Act by extending the 

requirement for electronic submission of 

registration information to include 

domestic firms as well as foreign firms. 

However, when adding these new 

electronic submission requirements, 

which appear in section 510(p) of the 

FD&C Act, Congress chose to delay their 

implementation so that FDA would 

have an opportunity to first put systems 

in place to accommodate the electronic 

receipt of registration information. This 

was accomplished by including a 


sroberts on DSK5SPTVN1PROD with RULES