Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments, 71139-71142 [2021-27055]

Download as PDF Federal Register / Vol. 86, No. 238 / Wednesday, December 15, 2021 / Rules and Regulations 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. Lists of Subjects in 14 CFR Part 97 Air traffic control, Airports, Incorporation by reference, Navigation (air). Issued in Washington, DC, on November 26, 2021. Thomas J. Nichols, Aviation Safety, Flight Standards Service, Manager, Standards Section, Flight Procedures & Airspace Group, Flight Technologies & Procedures Division. khammond on DSKJM1Z7X2PROD with RULES Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CRF 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: VerDate Sep<11>2014 16:21 Dec 14, 2021 Jkt 256001 PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: 71139 DEPARTMENT OF TRANSPORTATION Federal Aviation Administration ■ Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. 2. Part 97 is amended to read as follows: ■ Effective 30 December 2021 Boston, MA, KBOS, RNAV (RNP) X RWY 33L, Orig Portsmouth, NH, KPSM, ILS OR LOC RWY 16, Amdt 3A Portsmouth, NH, KPSM, RNAV (GPS) RWY 16, Amdt 3A New York, NY, KLGA, ILS OR LOC RWY 4, Amdt 38 New York, NY, KLGA, RNAV (GPS) Y RWY 4, Amdt 4 New York, NY, KLGA, RNAV (RNP) Z RWY 4, Amdt 2 Effective 27 January 2022 Kodiak, AK, PADQ, ILS Y OR LOC Y RWY 26, Amdt 4 Headland, AL, KHDL, RNAV (GPS) RWY 9, Amdt 1B Headland, AL, KHDL, RNAV (GPS) RWY 27, Amdt 1B Orlando, FL, KMCO, RNAV (GPS) RWY 17L, Amdt 2B Donalsonville, GA, Donalsonville Muni, Takeoff Minimums and Obstacle DP, Amdt 1 Spencer, IA, KSPW, RNAV (GPS) RWY 12, Amdt 1 Spencer, IA, KSPW, RNAV (GPS) RWY 30, Amdt 1C Spencer, IA, KSPW, RNAV (GPS) RWY 36, Amdt 1B Huntington, IN, KHHG, RNAV (GPS) RWY 10, Amdt 1 Huntington, IN, KHHG, RNAV (GPS) RWY 28, Amdt 1 Marshall, MI, KRMY, VOR/DME–A, Orig-B, CANCELLED Jackson, MN, KMJQ, RNAV (GPS) RWY 13, Amdt 2 Moberly, MO, KMBY, RNAV (GPS) RWY 13, Amdt 1 Moberly, MO, KMBY, RNAV (GPS) RWY 31, Amdt 1 Moberly, MO, Omar N Bradley, Takeoff Minimums and Obstacle DP, Amdt 1 Grand Island, NE, KGRI, ILS OR LOC RWY 35, Amdt 10 Wurtsboro, NY, Wurtsboro-Sullivan County, Takeoff Minimums and Obstacle DP, Amdt 2A Burnet, TX, KBMQ, RNAV (GPS) RWY 19, Orig-D [FR Doc. 2021–27054 Filed 12–14–21; 8:45 am] BILLING CODE 4910–13–P PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 14 CFR Part 97 [Docket No. 31403; Amdt. No. 3986] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments Federal Aviation Administration (FAA), DOT. ACTION: Final rule. AGENCY: This rule amends, suspends, or removes 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 for the 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 December 15, 2021. 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 December 15, 2021. ADDRESSES: Availability of matter incorporated by reference in the amendment is as follows: SUMMARY: 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 Information Services, 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, email fr.inspection@nara.gov or go to: https:// www.archives.gov/federal-register/cfr/ ibr-locations.html. E:\FR\FM\15DER1.SGM 15DER1 71140 Federal Register / Vol. 86, No. 238 / Wednesday, December 15, 2021 / Rules and Regulations Availability All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online 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: Thomas J. Nichols, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104, Oklahoma City, OK 73169. Telephone: (405) 954–4164. This rule amends 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 (NFDC)/Permanent Notice to Airmen (P–NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. 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 on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number. SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with RULES AIRAC date 30–Dec–21 .. VerDate Sep<11>2014 State NH 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 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 and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs. The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, 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 that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days. 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 these 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 City Airport Haverhill ................... Dean Meml ............................... 16:21 Dec 14, 2021 Jkt 256001 PO 00000 Frm 00012 Fmt 4700 FDC No. Sfmt 4700 1/2641 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 November 26, 2021. Thomas J. Nichols, Aviation Safety, Flight Standards Service Manager, Standards Section, Flight Procedures & Airspace Group, Flight Technologies & Procedures Division. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, Title 14, CFR part 97, (is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, 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(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. 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 FDC date 9/3/21 E:\FR\FM\15DER1.SGM Subject This NOTAM, published in Docket No. 31401, Amdt No. 3984, TL 22–01, (86 FR 68541, December 3, 2021), is hereby rescinded in its entirety. 15DER1 Federal Register / Vol. 86, No. 238 / Wednesday, December 15, 2021 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES AIRAC date State City Airport FDC No. FDC date 30–Dec–21 .. IA Hampton .................. Hampton Muni .......................... 1/6841 10/27/21 30–Dec–21 .. KS Wichita ..................... Colonel James Jabara .............. 1/8670 8/16/21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 .. .. .. .. .. .. IA MI SC MO MO KS Hampton .................. Bellaire ..................... Columbia ................. Aurora ...................... Aurora ...................... Wichita ..................... 1/0780 1/0823 1/1158 1/1417 1/1419 1/1513 11/23/21 11/23/21 11/10/21 11/9/21 11/9/21 11/9/21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 .. .. .. .. .. .. .. MN MN MN MN MN IA IA Worthington ............. Worthington ............. Worthington ............. Worthington ............. Worthington ............. Ottumwa .................. Ottumwa .................. Hampton Muni .......................... Antrim County ........................... Columbia Metro ........................ Jerry Sumners Sr Aurora Muni Jerry Sumners Sr Aurora Muni Wichita Dwight D Eisenhower Ntl. Worthington Muni ..................... Worthington Muni ..................... Worthington Muni ..................... Worthington Muni ..................... Worthington Muni ..................... Ottumwa Rgnl ........................... Ottumwa Rgnl ........................... 1/2202 1/2203 1/2204 1/2205 1/2208 1/2220 1/2221 11/9/21 11/9/21 11/9/21 11/9/21 11/9/21 11/9/21 11/9/21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. IA IA IA TX TX MN MN MN MN NY IL IL TX TX IL IL NC NY KS Ottumwa .................. Ottumwa .................. Ottumwa .................. Jasper ...................... Jasper ...................... International Falls .... International Falls .... International Falls .... International Falls .... Batavia ..................... Salem ...................... Salem ...................... Houston ................... Houston ................... Flora ........................ Flora ........................ Hickory ..................... Millbrook .................. Wichita ..................... 1/2222 1/2223 1/2224 1/3206 1/3207 1/3225 1/3227 1/3231 1/3233 1/3291 1/4314 1/4315 1/4390 1/4391 1/4418 1/4420 1/5283 1/5336 1/5763 11/9/21 11/9/21 11/9/21 11/9/21 11/9/21 11/10/21 11/10/21 11/10/21 11/10/21 11/9/21 11/10/21 11/10/21 11/10/21 11/10/21 11/12/21 11/12/21 11/10/21 11/10/21 11/9/21 30–Dec–21 .. KS Wichita ..................... 1/5764 11/9/21 30–Dec–21 .. MA Boston ..................... 1/5872 11/10/21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 .. .. .. .. OH WI WI MS Shelby ...................... Kenosha .................. Kenosha .................. Hattiesburg .............. 1/5921 1/6158 1/6160 1/6996 11/12/21 11/12/21 11/12/21 11/15/21 30–Dec–21 .. MS Hattiesburg .............. 1/6997 11/15/21 30–Dec–21 .. 30–Dec–21 .. FL FL Jacksonville ............. Jacksonville ............. Ottumwa Rgnl ........................... Ottumwa Rgnl ........................... Ottumwa Rgnl ........................... Jasper County-Bell Fld ............. Jasper County-Bell Fld ............. Falls Intl-Einarson Fld ............... Falls Intl-Einarson Fld ............... Falls Intl-Einarson Fld ............... Falls Intl-Einarson Fld ............... Genesee County ....................... Salem-Leckrone ........................ Salem-Leckrone ........................ Houston Exec ........................... Houston Exec ........................... Flora Muni ................................. Flora Muni ................................. Hickory Rgnl ............................. Sky Acres ................................. Wichita Dwight D Eisenhower Ntl. Wichita Dwight D Eisenhower Ntl. General Edward Lawrence Logan Intl. Shelby Community ................... Kenosha Rgnl ........................... Kenosha Rgnl ........................... Hattiesburg Bobby L Chain Muni. Hattiesburg Bobby L Chain Muni. Jacksonville Intl ........................ Jacksonville Intl ........................ 1/7884 1/7887 11/10/21 11/10/21 30–Dec–21 .. FL Jacksonville ............. Jacksonville Intl ........................ 1/7889 11/10/21 30–Dec–21 .. FL Jacksonville ............. Jacksonville Intl ........................ 1/7891 11/10/21 30–Dec–21 .. FL Jacksonville ............. Jacksonville Intl ........................ 1/7894 11/10/21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 NY NY NY SC SC SC SC SC SC Batavia ..................... Batavia ..................... Batavia ..................... Columbia ................. Columbia ................. Columbia ................. Columbia ................. Columbia ................. Columbia ................. Genesee County ....................... Genesee County ....................... Genesee County ....................... Columbia Metro ........................ Columbia Metro ........................ Columbia Metro ........................ Columbia Metro ........................ Columbia Metro ........................ Columbia Metro ........................ 1/8401 1/8417 1/9021 1/9033 1/9035 1/9038 1/9041 1/9044 1/9046 11/9/21 11/9/21 11/9/21 11/10/21 11/10/21 11/10/21 11/10/21 11/10/21 11/10/21 .. .. .. .. .. .. .. .. .. VerDate Sep<11>2014 16:21 Dec 14, 2021 Jkt 256001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\15DER1.SGM 71141 Subject This NOTAM, published in Docket No. 31401, Amdt No. 3984, TL 22–01, (86 FR 68541, December 3, 2021), is hereby rescinded in its entirety. This NOTAM, published in Docket No. 31401, Amdt No. 3984, TL 22–01, (86 FR 68541, December 3, 2021), is hereby rescinded in its entirety. VOR/DME RWY 35, Amdt 1F. RNAV (GPS) RWY 2, Orig. ILS OR LOC RWY 5, Amdt 1E. RNAV (GPS) RWY 18, Orig-B. RNAV (GPS) RWY 36, Orig-B. ILS OR LOC RWY 1L, Amdt 3C. RNAV (GPS) RWY 18, Orig-B. RNAV (GPS) RWY 11, Orig-A. RNAV (GPS) RWY 29, Orig-A. RNAV (GPS) RWY 36, Orig-A. ILS OR LOC RWY 29, Amdt 1A. ILS OR LOC RWY 31, Amdt 5E. LOC/DME BC RWY 13, Amdt 3B. RNAV (GPS) RWY 13, Orig-B. RNAV (GPS) RWY 31, Orig. VOR/DME RWY 13, Amdt 7B. RNAV (GPS) RWY 18, Orig. RNAV (GPS) RWY 36, Orig-B. VOR RWY 31, Amdt 15B. VOR RWY 13, Amdt 14A. RNAV (GPS) RWY 31, Orig-A. RNAV (GPS) RWY 13, Orig-A. RNAV (GPS) RWY 10, Orig-B. RNAV (GPS) RWY 18, Amdt 1A. RNAV (GPS) RWY 36, Amdt 1A. RNAV (GPS) RWY 18, Orig-A. RNAV (GPS) RWY 36, Amdt 1. RNAV (GPS) RWY 21, Amdt 2D. RNAV (GPS) RWY 3, Amdt 2B. RNAV (GPS) RWY 1, Amdt 1B. VOR–A, Amdt 8. ILS OR LOC RWY 19R, Amdt 5G. ILS OR LOC RWY 1R, Amdt 17D. RNAV (GPS) RWY 33L, Amdt 2C. VOR–A, Amdt 5A. RNAV (GPS) RWY 15, Orig-B. RNAV (GPS) RWY 33, Orig-B. RNAV (GPS) Y RWY 13, Amdt 2B. RNAV (GPS) Z RWY 13, Amdt 1B. VOR/DME RWY 32, Amdt 2B. RNAV (GPS) Z RWY 32, Amdt 2D. RNAV (GPS) Z RWY 26, Amdt 2C. RNAV (GPS) Z RWY 14, Amdt 2B. RNAV (GPS) Z RWY 8, Amdt 2B. VOR/DME–A, Amdt 5B. ILS OR LOC RWY 28, Amdt 6B. RNAV (GPS) RWY 28, Orig. VOR–A, Amdt 16A. RNAV (GPS) RWY 29, Amdt 1C. RNAV (GPS) RWY 23, Amdt 2B. RNAV (GPS) RWY 11, Amdt 1C. RNAV (GPS) RWY 5, Amdt 2C. ILS OR LOC RWY 29, Amdt 3I. 15DER1 71142 Federal Register / Vol. 86, No. 238 / Wednesday, December 15, 2021 / Rules and Regulations AIRAC date State City Airport FDC date 30–Dec–21 .. SC Columbia ................. Columbia Metro ........................ 1/9048 11/10/21 30–Dec–21 30–Dec–21 30–Dec–21 30–Dec–21 TX CA CA NH Fredericksburg ......... Riverside .................. Riverside .................. Haverhill ................... Gillespie County ....................... Riverside Muni .......................... Riverside Muni .......................... Dean Meml ............................... 1/9053 1/9359 1/9373 1/9780 11/10/21 11/5/21 11/5/21 9/3/21 .. .. .. .. [FR Doc. 2021–27055 Filed 12–14–21; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA–2021–N–0583] Medical Devices; GastroenterologyUrology Devices; Classification of the Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. The Food and Drug Administration (FDA or we) is classifying the nonimplanted nerve stimulator for functional abdominal pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nonimplanted nerve stimulator for functional abdominal pain relief’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices. DATES: This order is effective December 15, 2021. The classification was applicable on June 7, 2019. FOR FURTHER INFORMATION CONTACT: Pamela Scott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4208, Silver Spring, MD 20993–0002, 301–796–5433, PamelaD.Scott@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: khammond on DSKJM1Z7X2PROD with RULES FDC No. I. Background Upon request, FDA has classified the nonimplanted nerve stimulator for functional abdominal pain relief as class II (special controls), which we have determined will provide a reasonable VerDate Sep<11>2014 16:21 Dec 14, 2021 Jkt 256001 assurance of safety and effectiveness. In addition, we believe this action will enhance patients’ access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). FDA may also classify a device through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105– 115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112–144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 Subject ILS OR LOC RWY 11, Amdt 15A. VOR/DME–A, Amdt 3B. RNAV (GPS) RWY 9, Amdt 2C. ILS OR LOC RWY 9, Amdt 8D. RNAV (GPS) RWY 19, Orig. then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ‘‘substantial equivalence’’). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On October 25, 2018, Innovative Health Solutions, Inc. submitted a request for De Novo classification of the IB-Stim. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify 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 that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA E:\FR\FM\15DER1.SGM 15DER1

Agencies

[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Rules and Regulations]
[Pages 71139-71142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27055]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31403; Amdt. No. 3986]


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 amends, suspends, or removes 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 for the 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 December 15, 2021. 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 December 15, 2021.

ADDRESSES: Availability of matter 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 Information Services, 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, email 
[email protected] or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

[[Page 71140]]

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free 
of charge. Visit the National Flight Data Center online 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: Thomas J. Nichols, Flight Procedures 
and Airspace Group, Flight Technologies and Procedures Division, Flight 
Standards Service, Federal Aviation Administration. Mailing Address: 
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace 
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104, 
Oklahoma City, OK 73169. Telephone: (405) 954-4164.

SUPPLEMENTARY INFORMATION: This rule amends 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 (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is 
incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 
CFR 97.20. 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 on FAA form 
documents is unnecessary. This amendment provides the affected CFR 
sections, and specifies the SIAPs and 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 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 and Takeoff Minimums and ODP as amended in the 
transmittal. For safety and timeliness of change considerations, this 
amendment incorporates only specific changes contained for each SIAP 
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC 
permanent NOTAM, and contained in this amendment are based on criteria 
contained in the U.S. Standard for Terminal Instrument Procedures 
(TERPS). In developing these changes to SIAPs and Takeoff Minimums and 
ODPs, 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 that created the need for these SIAP and Takeoff 
Minimums and ODP amendments require making them effective in less than 
30 days.
    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 these 
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 November 26, 2021.
Thomas J. Nichols,
Aviation Safety, Flight Standards Service Manager, Standards Section, 
Flight Procedures & Airspace Group, Flight Technologies & Procedures 
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14, 
CFR part 97, (is amended by amending Standard Instrument Approach 
Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the 
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.


0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or 
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.  
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; 
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER 
SIAPs, Identified as follows:

* * * Effective Upon Publication

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      AIRAC date           State             City                 Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
30-Dec-21.............  NH           Haverhill...........  Dean Meml...........       1/2641       9/3/21  This NOTAM, published in Docket No. 31401,
                                                                                                            Amdt No. 3984, TL 22-01, (86 FR 68541,
                                                                                                            December 3, 2021), is hereby rescinded in
                                                                                                            its entirety.

[[Page 71141]]

 
30-Dec-21.............  IA           Hampton.............  Hampton Muni........       1/6841     10/27/21  This NOTAM, published in Docket No. 31401,
                                                                                                            Amdt No. 3984, TL 22-01, (86 FR 68541,
                                                                                                            December 3, 2021), is hereby rescinded in
                                                                                                            its entirety.
30-Dec-21.............  KS           Wichita.............  Colonel James Jabara       1/8670      8/16/21  This NOTAM, published in Docket No. 31401,
                                                                                                            Amdt No. 3984, TL 22-01, (86 FR 68541,
                                                                                                            December 3, 2021), is hereby rescinded in
                                                                                                            its entirety.
30-Dec-21.............  IA           Hampton.............  Hampton Muni........       1/0780     11/23/21  VOR/DME RWY 35, Amdt 1F.
30-Dec-21.............  MI           Bellaire............  Antrim County.......       1/0823     11/23/21  RNAV (GPS) RWY 2, Orig.
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/1158     11/10/21  ILS OR LOC RWY 5, Amdt 1E.
30-Dec-21.............  MO           Aurora..............  Jerry Sumners Sr           1/1417      11/9/21  RNAV (GPS) RWY 18, Orig-B.
                                                            Aurora Muni.
30-Dec-21.............  MO           Aurora..............  Jerry Sumners Sr           1/1419      11/9/21  RNAV (GPS) RWY 36, Orig-B.
                                                            Aurora Muni.
30-Dec-21.............  KS           Wichita.............  Wichita Dwight D           1/1513      11/9/21  ILS OR LOC RWY 1L, Amdt 3C.
                                                            Eisenhower Ntl.
30-Dec-21.............  MN           Worthington.........  Worthington Muni....       1/2202      11/9/21  RNAV (GPS) RWY 18, Orig-B.
30-Dec-21.............  MN           Worthington.........  Worthington Muni....       1/2203      11/9/21  RNAV (GPS) RWY 11, Orig-A.
30-Dec-21.............  MN           Worthington.........  Worthington Muni....       1/2204      11/9/21  RNAV (GPS) RWY 29, Orig-A.
30-Dec-21.............  MN           Worthington.........  Worthington Muni....       1/2205      11/9/21  RNAV (GPS) RWY 36, Orig-A.
30-Dec-21.............  MN           Worthington.........  Worthington Muni....       1/2208      11/9/21  ILS OR LOC RWY 29, Amdt 1A.
30-Dec-21.............  IA           Ottumwa.............  Ottumwa Rgnl........       1/2220      11/9/21  ILS OR LOC RWY 31, Amdt 5E.
30-Dec-21.............  IA           Ottumwa.............  Ottumwa Rgnl........       1/2221      11/9/21  LOC/DME BC RWY 13, Amdt 3B.
30-Dec-21.............  IA           Ottumwa.............  Ottumwa Rgnl........       1/2222      11/9/21  RNAV (GPS) RWY 13, Orig-B.
30-Dec-21.............  IA           Ottumwa.............  Ottumwa Rgnl........       1/2223      11/9/21  RNAV (GPS) RWY 31, Orig.
30-Dec-21.............  IA           Ottumwa.............  Ottumwa Rgnl........       1/2224      11/9/21  VOR/DME RWY 13, Amdt 7B.
30-Dec-21.............  TX           Jasper..............  Jasper County-Bell         1/3206      11/9/21  RNAV (GPS) RWY 18, Orig.
                                                            Fld.
30-Dec-21.............  TX           Jasper..............  Jasper County-Bell         1/3207      11/9/21  RNAV (GPS) RWY 36, Orig-B.
                                                            Fld.
30-Dec-21.............  MN           International Falls.  Falls Intl-Einarson        1/3225     11/10/21  VOR RWY 31, Amdt 15B.
                                                            Fld.
30-Dec-21.............  MN           International Falls.  Falls Intl-Einarson        1/3227     11/10/21  VOR RWY 13, Amdt 14A.
                                                            Fld.
30-Dec-21.............  MN           International Falls.  Falls Intl-Einarson        1/3231     11/10/21  RNAV (GPS) RWY 31, Orig-A.
                                                            Fld.
30-Dec-21.............  MN           International Falls.  Falls Intl-Einarson        1/3233     11/10/21  RNAV (GPS) RWY 13, Orig-A.
                                                            Fld.
30-Dec-21.............  NY           Batavia.............  Genesee County......       1/3291      11/9/21  RNAV (GPS) RWY 10, Orig-B.
30-Dec-21.............  IL           Salem...............  Salem-Leckrone......       1/4314     11/10/21  RNAV (GPS) RWY 18, Amdt 1A.
30-Dec-21.............  IL           Salem...............  Salem-Leckrone......       1/4315     11/10/21  RNAV (GPS) RWY 36, Amdt 1A.
30-Dec-21.............  TX           Houston.............  Houston Exec........       1/4390     11/10/21  RNAV (GPS) RWY 18, Orig-A.
30-Dec-21.............  TX           Houston.............  Houston Exec........       1/4391     11/10/21  RNAV (GPS) RWY 36, Amdt 1.
30-Dec-21.............  IL           Flora...............  Flora Muni..........       1/4418     11/12/21  RNAV (GPS) RWY 21, Amdt 2D.
30-Dec-21.............  IL           Flora...............  Flora Muni..........       1/4420     11/12/21  RNAV (GPS) RWY 3, Amdt 2B.
30-Dec-21.............  NC           Hickory.............  Hickory Rgnl........       1/5283     11/10/21  RNAV (GPS) RWY 1, Amdt 1B.
30-Dec-21.............  NY           Millbrook...........  Sky Acres...........       1/5336     11/10/21  VOR-A, Amdt 8.
30-Dec-21.............  KS           Wichita.............  Wichita Dwight D           1/5763      11/9/21  ILS OR LOC RWY 19R, Amdt 5G.
                                                            Eisenhower Ntl.
30-Dec-21.............  KS           Wichita.............  Wichita Dwight D           1/5764      11/9/21  ILS OR LOC RWY 1R, Amdt 17D.
                                                            Eisenhower Ntl.
30-Dec-21.............  MA           Boston..............  General Edward             1/5872     11/10/21  RNAV (GPS) RWY 33L, Amdt 2C.
                                                            Lawrence Logan Intl.
30-Dec-21.............  OH           Shelby..............  Shelby Community....       1/5921     11/12/21  VOR-A, Amdt 5A.
30-Dec-21.............  WI           Kenosha.............  Kenosha Rgnl........       1/6158     11/12/21  RNAV (GPS) RWY 15, Orig-B.
30-Dec-21.............  WI           Kenosha.............  Kenosha Rgnl........       1/6160     11/12/21  RNAV (GPS) RWY 33, Orig-B.
30-Dec-21.............  MS           Hattiesburg.........  Hattiesburg Bobby L        1/6996     11/15/21  RNAV (GPS) Y RWY 13, Amdt 2B.
                                                            Chain Muni.
30-Dec-21.............  MS           Hattiesburg.........  Hattiesburg Bobby L        1/6997     11/15/21  RNAV (GPS) Z RWY 13, Amdt 1B.
                                                            Chain Muni.
30-Dec-21.............  FL           Jacksonville........  Jacksonville Intl...       1/7884     11/10/21  VOR/DME RWY 32, Amdt 2B.
30-Dec-21.............  FL           Jacksonville........  Jacksonville Intl...       1/7887     11/10/21  RNAV (GPS) Z RWY 32, Amdt 2D.
30-Dec-21.............  FL           Jacksonville........  Jacksonville Intl...       1/7889     11/10/21  RNAV (GPS) Z RWY 26, Amdt 2C.
30-Dec-21.............  FL           Jacksonville........  Jacksonville Intl...       1/7891     11/10/21  RNAV (GPS) Z RWY 14, Amdt 2B.
30-Dec-21.............  FL           Jacksonville........  Jacksonville Intl...       1/7894     11/10/21  RNAV (GPS) Z RWY 8, Amdt 2B.
30-Dec-21.............  NY           Batavia.............  Genesee County......       1/8401      11/9/21  VOR/DME-A, Amdt 5B.
30-Dec-21.............  NY           Batavia.............  Genesee County......       1/8417      11/9/21  ILS OR LOC RWY 28, Amdt 6B.
30-Dec-21.............  NY           Batavia.............  Genesee County......       1/9021      11/9/21  RNAV (GPS) RWY 28, Orig.
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/9033     11/10/21  VOR-A, Amdt 16A.
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/9035     11/10/21  RNAV (GPS) RWY 29, Amdt 1C.
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/9038     11/10/21  RNAV (GPS) RWY 23, Amdt 2B.
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/9041     11/10/21  RNAV (GPS) RWY 11, Amdt 1C.
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/9044     11/10/21  RNAV (GPS) RWY 5, Amdt 2C.
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/9046     11/10/21  ILS OR LOC RWY 29, Amdt 3I.

[[Page 71142]]

 
30-Dec-21.............  SC           Columbia............  Columbia Metro......       1/9048     11/10/21  ILS OR LOC RWY 11, Amdt 15A.
30-Dec-21.............  TX           Fredericksburg......  Gillespie County....       1/9053     11/10/21  VOR/DME-A, Amdt 3B.
30-Dec-21.............  CA           Riverside...........  Riverside Muni......       1/9359      11/5/21  RNAV (GPS) RWY 9, Amdt 2C.
30-Dec-21.............  CA           Riverside...........  Riverside Muni......       1/9373      11/5/21  ILS OR LOC RWY 9, Amdt 8D.
30-Dec-21.............  NH           Haverhill...........  Dean Meml...........       1/9780       9/3/21  RNAV (GPS) RWY 19, Orig.
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[FR Doc. 2021-27055 Filed 12-14-21; 8:45 am]
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