### 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.


### 10585 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations

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


### 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—C ITATIONS IN 

### P ART 

### 803; UDI C ITATION AND 

### C ORRESPONDING 

### U PDATED 

### C ITATION

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).

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

2 The ‘‘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