10584 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 

AIRAC Date State City Airport FDC No. FDC Date Subject 

5–Mar–15 .......... NY Rochester ......................... Greater Rochester Intl ..... 5/2524 01/13/15 RNAV (GPS) RWY 28, 

Amdt 2. 

5–Mar–15 .......... NY Rochester ......................... Greater Rochester Intl ..... 5/2525 01/13/15 RNAV (GPS) RWY 10, 

Amdt 1. 

5–Mar–15 .......... NY Rochester ......................... Greater Rochester Intl ..... 5/2526 01/13/15 RNAV (GPS) RWY 7, 

Amdt 1. 

5–Mar–15 .......... NY Rochester ......................... Greater Rochester Intl ..... 5/2527 01/13/15 RNAV (GPS) RWY 25, 

Amdt 1. 

5–Mar–15 .......... NY Rochester ......................... Greater Rochester Intl ..... 5/2528 01/13/15 VOR RWY 4, Amdt 12. 

5–Mar–15 .......... NY Rochester ......................... Greater Rochester Intl ..... 5/2529 01/13/15 VOR/DME RWY 4, Amdt 

4. 

5–Mar–15 .......... NY Rochester ......................... Greater Rochester Intl ..... 5/2530 01/13/15 ILS OR LOC RWY 4, ILS 

RWY 4 (SA CAT I), ILS 

RWY 4 (CAT II), Amdt 

21. 

5–Mar–15 .......... MD Gaithersburg .................... Montgomery County Airpark.5/2542 01/13/15 RNAV (GPS) RWY 14, 

Amdt 3A. 

5–Mar–15 .......... MD Gaithersburg .................... Montgomery County Airpark.5/2543 01/13/15 RNAV (GPS)-A, Orig. 

5–Mar–15 .......... ME Portland ............................ Portland Intl Jetport .......... 5/2548 01/13/15 RNAV (GPS) RWY 18, 

Amdt 1. 

5–Mar–15 .......... ME Portland ............................ Portland Intl Jetport .......... 5/2549 01/13/15 RNAV (GPS) RWY 36, 

Amdt 1. 

5–Mar–15 .......... NH Manchester ...................... Manchester ...................... 5/2550 01/13/15 ILS OR LOC/DME RWY 

17, Amdt 2. 

5–Mar–15 .......... SC Charleston ........................ Charleston Executive ....... 5/2553 01/13/15 RNAV (GPS) RWY 27, 

Amdt 2. 

5–Mar–15 .......... GA Atlanta .............................. Covington Muni ................ 5/2559 01/13/15 NDB RWY 28, Amdt 3A. 

5–Mar–15 .......... GA Atlanta .............................. Covington Muni ................ 5/2560 01/13/15 RNAV (GPS) RWY 28, 

Amdt 1A. 

5–Mar–15 .......... GA Atlanta .............................. Covington Muni ................ 5/2561 01/13/15 RNAV (GPS) RWY 10, 

Amdt 1. 

5–Mar–15 .......... GA Atlanta .............................. Covington Muni ................ 5/2562 01/13/15 VOR/DME RWY 10, Amdt 

5A. 

5–Mar–15 .......... FL Punta Gorda ..................... Punta Gorda ..................... 5/2563 01/13/15 VOR RWY 22, Amdt 4B. 

5–Mar–15 .......... NY Farmingdale ..................... Republic ........................... 5/2583 01/13/15 RNAV (GPS) Y RWY 14, 

Amdt 2B. 

5–Mar–15 .......... FL Tampa .............................. Tampa Executive ............. 5/2825 01/13/15 RNAV (GPS) RWY 5, 

Orig-A. 

5–Mar–15 .......... FL Tampa .............................. Tampa Executive ............. 5/2826 01/13/15 ILS OR LOC RWY 23, 

Amdt 1B. 

5–Mar–15 .......... FL Tampa .............................. Tampa Executive ............. 5/2827 01/13/15 RNAV (GPS) RWY 23, 

Amdt 1B. 

[FR Doc. 2015–03932 Filed 2–26–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30999; Amdt. No. 3627] 

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 removes Standard 

Instrument Approach Procedures 

(SIAPs) and associated Takeoff 

Minimums and Obstacle Departure 

Procedures (ODPs) 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 February 

27, 2015. 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 February 

27, 2015. 

ADDRESSES: Availability of matters 

incorporated by reference in the 

amendment is as follows: 

For Examination 

1. U.S. Department of Transportation, 

Docket Ops–M30, 1200 New Jersey 

Avenue SE., West Bldg., Ground Floor, 

Washington, DC 20590–0001; 

2. The FAA Air Traffic Organization 

Service Area in which the affected 

airport is located; 

3. The office of Aeronautical 

Navigation Products, 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. 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 10585 

Availability 

All SIAPs and Takeoff Minimums and 

ODPs are available online free of charge. 

Visit the National Flight Data Center at 

nfdc.faa.gov to register. Additionally, 

individual SIAP and Takeoff Minimums 

and ODP copies may be obtained from 

the FAA Air Traffic Organization 

Service Area 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 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 

removes SIAPS, Takeoff Minimums 

and/or ODPS. The complete regulatory 

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, their complex 

nature, and the need for a special format 

make publication in the Federal 

Register expensive and impractical. 

Further, airmen do not use the 

regulatory text of the SIAPs, Takeoff 

Minimums or ODPs, but instead 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, Takeoff 

Minimums and ODP listed on FAA form 

documents is unnecessary. This 

amendment provides the affected CFR 

sections and specifies the types of 

SIAPs, Takeoff Minimums and ODPs 

with their applicable effective dates. 

This amendment also identifies the 

airport and its location, the procedure, 

and the amendment number. 

Availability and Summary of Material 

Incorporated by Reference 

The material incorporated by 

reference is publicly available as listed 

in the ADDRESSES section. 

The material incorporated by 

reference describes SIAPS, Takeoff 

Minimums and/or ODPS as identified in 

the amendatory language for part 97 of 

this final rule. 

The Rule 

This amendment to 14 CFR part 97 is 

effective upon publication of each 

separate SIAP, Takeoff Minimums and 

ODP as Amended 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 that 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 procedure under 

5 U.S.C. 553(b) are impracticable and 

contrary to the public interest and, 

where applicable, under 5 U.S.C 553(d), 

good cause exists for making some 

SIAPs effective in less than 30 days. 

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, Navigation 

(air). 

Issued in Washington, DC, on January 16, 

2015. 

John Duncan, 

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 

removing Standard Instrument 

Approach Procedures and/or Takeoff 

Minimums and Obstacle Departure 

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: 

Effective 5 March 2015 

San Francisco, CA, San Francisco Intl, 

ILS OR LOC RWY 28R, ILS RWY 28R 

(CAT II), ILS RWY 28R (CAT III), ILS 

RWY 28R (SA CAT I), Amdt 13 

San Francisco, CA, San Francisco Intl, 

RNAV (GPS) RWY 28L, Amdt 5 

San Francisco, CA, San Francisco Intl, 

RNAV (GPS) Z RWY 28R, Amdt 5 

Baltimore, MD, Martin State, Takeoff 

Minimums and Obstacle DP, Amdt 5 

Easton, MD, Easton/Newman Field, 

Takeoff Minimums and Obstacle DP, 

Amdt 1 

Gaithersburg, MD, Montgomery County 

Airpark, Takeoff Minimums and 

Obstacle DP, Amdt 1 

Westminster, MD, Carroll County Rgnl/ 

Jack B Poage Field, Takeoff 

Minimums and Obstacle DP, Amdt 6 

Great Falls, MT, Great Falls Intl, RNAV 

(RNP) Z RWY 21, Orig–C 

Prineville, OR, Prineville, NDB RWY 10, 

Amdt 1, CANCELED 

Ponce, PR, Mercedita, Takeoff 

Minimums and Obstacle DP, Amdt 4 

Ponce, PR, Mercedita, VOR–A, Orig, 

CANCELED 

Houston, TX, George Bush 

Intercontinental/Houston, ILS OR 

LOC RWY 8L, ILS RWY 8L (CAT II), 

ILS RWY 8L (CAT III), ILS RWY 8L 

(SA CAT I), Amdt 4B 

Houston, TX, George Bush 

Intercontinental/Houston, RNAV 

(GPS) Z RWY 8L, Amdt 5B 

Price, UT, Carbon County Rgnl/Buck 

Davis Field, ILS OR LOC/DME RWY 

1, Amdt 1 

Price, UT, Carbon County Rgnl/Buck 

Davis Field, Takeoff Minimums and 

Obstacle DP, Amdt 5 


tkelley on DSK3SPTVN1PROD with RULES
10586 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 

Price, UT, Carbon County Rgnl/Buck 

Davis Field, VOR RWY 36, Amdt 2, 

CANCELED 

Price, UT, Carbon County Rgnl/Buck 

Davis Field, VOR/DME RWY 1, Amdt 

1 

Effective 2 April 2015 

Truckee, CA, Truckee-Tahoe, RNAV 

(GPS) Z RWY 20, Orig–A 

RESCINDED: On January 15, 2015 (80 

FR 2009), the FAA published an 

Amendment in Docket No. 30990, Amdt 

No. 3619, to Part 97 of the Federal 

Aviation Regulations under section 

97.23, 97.27, and 97.29. The following 

entries for Baton Rouge, LA, effective 

January 8, 2015 are hereby rescinded in 

their entirety: 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, ILS OR 

LOC RWY 13, Amdt 27E 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, ILS OR 

LOC RWY 22R, Amdt 11B 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, NDB RWY 

31, Amdt 2D 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, VOR RWY 

4L, Amdt 17C 

Baton Rouge, LA, Baton Rouge 

Metropolitan, Ryan Field, VOR/DME 

RWY 22R, Amdt 8H 

[FR Doc. 2015–03931 Filed 2–26–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2008–N–0393] 

RIN 0910–AF86 

Medical Device Reporting: Electronic 

Submission Requirements; Correcting 

Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; correcting 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulation regarding postmarket 

electronic Medical Device Reporting 

(eMDR) to address the unintentional 

removal of certain provisions of the 

Unique Device Identification (UDI) 

System regulations and to update the 

contact information listed in the 

regulations. 

DATES: This rule is effective August 14, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Kapsch, Office of Surveillance 

and Biometrics, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3208, Silver Spring, 

MD 20993–0002, 301–796–6104, 

Sharon.Kapsch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 24, 2013 

(78 FR 58786), FDA published the 

‘‘Unique Device Identification System’’ 

final rule (UDI rule). The UDI rule, 

among other things, amended part 803 

(21 CFR part 803). These amendments 

became effective on December 23, 2013. 

In the Federal Register of February 

14, 2014 (79 FR 8832), FDA published 

the ‘‘Medical Device Reporting: 

Electronic Submission Requirements’’ 

final rule (eMDR rule). The eMDR rule 

will become effective on August 14, 

2015. The eMDR rule, among other 

things, revises part 803 in its entirety. 

As published in the Federal Register, 

the eMDR rule will, upon its effective 

date, unintentionally remove the 

amendments made by the UDI rule to 

part 803 of the Code of Federal 

Regulations (CFR), Title 21. This 

document addresses the unintentional 

removal by amending part 803 to 

include the UDI requirements. 

When the eMDR rule goes into effect, 

it will require changes to the CFR 

citations of some provisions within part 

803; consequently, some of the citations 

used by the UDI rule will have to be 

updated. The following table provides 

the ‘‘Original UDI Citation’’ (the citation 

used by the September 24, 2013, UDI 

rule) and the corresponding ‘‘Updated 

Citation’’ for provisions addressed in 

this document. 

TABLE 1—CITATIONS IN PART 803; UDI CITATION AND CORRESPONDING UPDATED CITATION

Provision Original UDI citation 1 Updated citation 2

Amendment of 803.3—Definitions of human cell, tissue, or cellular or tissuebased product (HCT/P) regulated as a device and unique device identifier 

(UDI).

Listed alphabetically within 

803.3.

803.3(aa) and 803.3(bb), respectively. 

Amendment of section 803.32 ................................................................................. 803.32(c)(6) ........................... 803.32(c)(4). 

Amendment of section 803.33 ................................................................................. 803.33(a)(7)(iv) ...................... 803.33(b)(7)(iv). 

Amendment of section 803.42 ................................................................................. 803.42(c)(6) ........................... 803.42(c)(4). 

Amendment of section 803.52 ................................................................................. 803.52(c)(6) ........................... 803.52(c)(4). 

1The ‘‘Original UDI Citation’’ is the citation within part 803, as amended by the UDI rule, which became effective on December 23, 2013. 

2The ‘‘Updated Citation’’ is the citation within part 803, after the changes made by the eMDR rule go into effect on August 14, 2015, and after 

those changes are further amended by the correcting amendments in this document. 

We are also updating the contact 

information listed in §§ 803.11 and 

803.33 for the Division of International 

and Consumer Education (DICE) 

(formerly the Division of Small 

Manufacturers, International and 

Consumer Assistance (DSMICA)). 

FDA is publishing this document as a 

final rule under the Administrative 

Procedures Act (5 U.S.C. 551, et seq.). 

FDA has determined that good cause 

exists to dispense with prior notice and 

public comment under 5 U.S.C. 

553(b)(3)(B) and 21 CFR 10.40(e)(1) 

because the provisions addressed in this 

document have already undergone 

notice and public comment. 

Additionally, the amendments to 

§§ 803.11 and 803.33, to provide 

updated contact information, are 

editorial in nature and are intended to 

improve the accuracy of the Agency’s 

regulations. 

FDA has determined under 21 CFR 

25.30(i) that this final rule is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This final rule refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA). The 

revised Form FDA 3500A is approved 

under OMB control number 0910–0291. 

The collections of information in part 

803 have been approved under OMB 


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