Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments, 71139-71142 [2021-27055]
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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
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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
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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
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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]
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. 2021-27055 Filed 12-14-21; 8:45 am]
BILLING CODE 4910-13-P
