Amendment and Establishment of Air Traffic Service (ATS) Routes; South Central United States, 66544-66545 [2022-23852]
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Federal Register / Vol. 87, No. 213 / Friday, November 4, 2022 / Rules and Regulations
Amendment Number 8, Effective
Date: March 24, 2020.
Amendment Number 9, Effective
Date: December 7, 2020.
Amendment Number 10, Effective
Date: January 18, 2023.
SAR Submitted by: NAC
International, Inc.
SAR Title: Final Safety Analysis
Report for the MAGNASTOR® System.
Docket Number: 72–1031.
Certificate Expiration Date: February
4, 2029.
Model Number: MAGNASTOR®.
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Counsel, AGC–300, Federal Aviation
Administration, (202) 267–7395.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of October 11,
2022, in FR Doc. 2022–21354, on page
61232, in the first column, correct the
RIN to read: RIN 2120–AL00.
Issued in Washington, DC, under the
authority provided by 49 U.S.C. 106(f), 40101
note and 44807, on October 21, 2022.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2022–23990 Filed 11–3–22; 8:45 am]
Dated: October 20, 2022.
For the Nuclear Regulatory Commission.
Daniel H. Dorman
Executive Director for Operations.
BILLING CODE 4910–13–P
[FR Doc. 2022–24010 Filed 11–3–22; 8:45 am]
Federal Aviation Administration
DEPARTMENT OF TRANSPORTATION
BILLING CODE 7590–01–P
14 CFR Part 71
DEPARTMENT OF TRANSPORTATION
[Docket No. FAA–2022–0436; Airspace
Docket No. 22–ASW–1]
Federal Aviation Administration
RIN 2120–AA66
14 CFR Part 13
Amendment and Establishment of Air
Traffic Service (ATS) Routes; South
Central United States
[Docket No.: FAA–2018–1051; Amdt. No.:
13–40A]
RIN 2120–AL00
Federal Aviation
Administration (FAA), U.S. Department
of Transportation (DOT).
ACTION: Final rule; correction.
AGENCY:
On October 11, 2022, the FAA
published a final rule titled ‘‘Update to
Investigative and Enforcement
Procedures and Part 11; Technical
Amendments.’’ That document made
technical amendments to the Update to
Investigative and Enforcement
Procedures final rule, which was
published on October 1, 2021. The
technical amendments rule
inadvertently identified the Rulemaking
Identification Number (RIN).
DATES: Effective November 4, 2022.
FOR FURTHER INFORMATION CONTACT: Cole
R. Milliard, Office of the Chief Counsel,
AGC–300, Federal Aviation
Administration, 800 Independence
Avenue SW, Washington, DC 20591;
telephone (202) 267–3452; email
Cole.Milliard@faa.gov, or Jessica E.
Kabaz-Gomez, Office of the Chief
SUMMARY:
khammond on DSKJM1Z7X2PROD with RULES
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; correction.
AGENCY:
Update to Investigative and
Enforcement Procedures and Part 11;
Correction
T–466
This action corrects a final
rule published by the FAA in the
Federal Register on October 27, 2022,
that amends VHF Omnidirectional
Range (VOR) Federal airways V–198, V–
212, V–556, and V–558; amends Area
Navigation (RNAV) route T–256; and
establishes RNAV route T–466. In the
new RNAV route T–466, the final rule
identified the CHILD, TX, route point as
a waypoint (WP) and the SEEDS, TX,
route point as a Fix, in error. This action
makes editorial corrections to the
reference of the CHILD, TX, WP to
change it to be reflected as a Fix and to
the SEEDS, TX, Fix to change it to be
reflected as a WP. These corrections are
necessary to match the FAA National
Airspace System Resource (NASR)
database information.
DATES: Effective date 0901 UTC,
December 29, 2022. The Director of the
Federal Register approves this
incorporation by reference action under
1 CFR part 51, subject to the annual
revision of FAA Order 7400.11 and
publication of conforming amendments.
SUMMARY:
17:31 Nov 03, 2022
History
The FAA published a final rule in the
Federal Register (87 FR 65011; October
27, 2022), amending VOR Federal
airways V–198, V–212, V–556, and V–
558; amending RNAV route T–256; and
establishing RNAV route T–466.
Subsequent to publication, the FAA
determined that the CHILD, TX, route
point was inadvertently identified as a
WP and the SEEDS, TX, route point was
inadvertently identified as a Fix, in
error. The correct route point references
are the CHILD, TX, Fix and the SEEDS,
TX, WP. This rule corrects those errors
by changing the reference of the CHILD,
TX, WP to the CHILD, TX, Fix; and the
reference of the SEEDS, TX, Fix to the
SEEDS, TX, WP.
These are editorial changes only to
match the FAA NASR database
information and do not alter the
alignment of the affected T–466 route.
United States Area Navigation Routes
are published in paragraph 6011 of FAA
Order JO 7400.11G, dated August 19,
2022, and effective September 15, 2022,
which is incorporated by reference in 14
CFR 71.1. The RNAV T-route listed in
this document will be published
subsequently in FAA Order JO 7400.11.
Correction to Final Rule
Accordingly, pursuant to the
authority delegated to me, references to
the CHILD, TX, WP and to the SEEDS,
TX, Fix that are reflected in Docket No.
FAA–2022–0436, as published in the
Federal Register of October 27, 2022 (87
FR 65011), FR Doc. 2022–22164, are
corrected as follows:
■ 1. On pages 65012 and 65013, correct
the table for T–466 San Angelo, TX
(SJT) to Sabine Pass, TX (SBI) [New] to
read:
San Angelo, TX (SJT) to Sabine Pass, TX (SBI) [New]
San Angelo, TX (SJT)
CHILD, TX
Junction, TX (JCT)
VerDate Sep<11>2014
FAA Order 7400.11G,
Airspace Designations and Reporting
Points, and subsequent amendments can
be viewed online at www.faa.gov/air_
traffic/publications/. For further
information, you can contact the Rules
and Regulations Group, Federal
Aviation Administration, 800
Independence Avenue SW, Washington,
DC 20591; telephone: (202) 267–8783.
FOR FURTHER INFORMATION CONTACT:
Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal
Aviation Administration, 800
Independence Avenue SW, Washington,
DC 20591; telephone: (202) 267–8783.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Jkt 259001
PO 00000
VORTAC
FIX
VORTAC
Frm 00010
(Lat. 31°22′29.84″ N, long. 100°27′17.53″ W)
(Lat. 31°03′41.17″ N, long. 100°27′40.62″ W)
(Lat. 30°35′52.88″ N, long. 099°49′02.93″ W)
Fmt 4700
Sfmt 4700
E:\FR\FM\04NOR1.SGM
04NOR1
Federal Register / Vol. 87, No. 213 / Friday, November 4, 2022 / Rules and Regulations
BETTI, TX
MARCS, TX
SEEDS, TX
LDRET, TX
KEEDS, TX
Scholes, TX (VUH)
Sabine Pass, TX (SBI)
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Issued in Washington, DC, on October 28,
2022.
Mark E. Gauch,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022–23852 Filed 11–3–22; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2020–N–2297]
Microbiology Devices; Reclassification
of Human Immunodeficiency Virus
Viral Load Monitoring Tests
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing a final order to reclassify
human immunodeficiency virus (HIV)
viral load monitoring tests,
postamendments class III devices with
the product code MZF, into class II
(special controls), subject to premarket
notification. Through this final order,
FDA is also adding a new device
classification regulation along with
special controls that are necessary to
provide a reasonable assurance of safety
and effectiveness for this device type.
The final order reclassifies this device
type from class III (premarket approval)
to class II (special controls) and will
reduce the regulatory burdens
associated with these devices because
manufacturers will no longer be
required to submit a premarket approval
application (PMA) for this device type
but can instead submit a less
burdensome premarket notification
(510(k)) and receive clearance before
marketing their device.
DATES: This order is effective December
5, 2022.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Review, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 72, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
17:31 Nov 03, 2022
Jkt 259001
FIX
FIX
WP
WP
WP
VOR/DME
VOR/DME
(Lat.
(Lat.
(Lat.
(Lat.
(Lat.
(Lat.
(Lat.
29°57′54.97″
29°53′52.04″
29°39′31.94″
29°39′44.93″
29°21′59.49″
29°16′09.60″
29°41′12.19″
N,
N,
N,
N,
N,
N,
N,
long.
long.
long.
long.
long.
long.
long.
098°03′23.98″
097°51′40.70″
097°14′58.66″
096°19′00.96″
095°36′48.98″
094°52′03.81″
094°02′16.72″
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115), the Medical
Device User Fee and Modernization Act
of 2002 (Pub. L. 107–250), the Medical
Devices Technical Corrections Act (Pub.
L. 108–214), the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), and the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
among other amendments, establishes a
comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories
(classes) of devices, reflecting the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (general controls and special
controls), and class III (general controls
and premarket approval).
Section 513(a)(1) of the FD&C Act
defines the three classes of devices.
Class I devices are those devices for
which the general controls of the FD&C
Act (controls authorized by or under
sections 501, 502, 510, 516, 518, 519, or
520 (21 U.S.C. 351, 352, 360, 360f, 360h,
360i, or 360j) or any combination of
such sections) are sufficient to provide
reasonable assurance of safety and
effectiveness; or those devices for which
insufficient information exists to
determine that general controls are
sufficient to provide reasonable
assurance of safety and effectiveness or
to establish special controls to provide
such assurance, but because the devices
are not purported or represented to be
for a use in supporting or sustaining
human life or for a use which is of
substantial importance in preventing
impairment of human health, and do
not present a potential unreasonable
risk of illness or injury, are to be
regulated by general controls (section
513(a)(1)(A) of the FD&C Act). Class II
devices are those devices for which
general controls by themselves are
insufficient to provide reasonable
assurance of safety and effectiveness
and for which there is sufficient
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
66545
W)
W)
W)
W)
W)
W)
W)
information to establish special controls
to provide such assurance, including the
promulgation of performance standards,
postmarket surveillance, patient
registries, development and
dissemination of guidelines,
recommendations, and other
appropriate actions the Agency deems
necessary to provide such assurance
(section 513(a)(1)(B) of the FD&C Act).
Class III devices are those devices for
which insufficient information exists to
determine that general controls and
special controls would provide a
reasonable assurance of safety and
effectiveness, and are purported or
represented to be for a use in supporting
or sustaining human life or for a use
which is of substantial importance in
preventing impairment of human
health, or present a potential
unreasonable risk of illness or injury
(section 513(a)(1)(C) of the FD&C Act).
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices) are
automatically classified by section
513(f)(1) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until: (1) FDA reclassifies the device
into class I or class II, or (2) FDA issues
an order finding the device to be
substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to
a predicate device that does not require
premarket approval. FDA determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act and part 807 (21 CFR part
807), subpart E, of the regulations.
A postamendments device that has
been initially classified in class III
under section 513(f)(1) of the FD&C Act
may be reclassified into class I or II
under section 513(f)(3) of the FD&C Act.
Section 513(f)(3) of the FD&C Act
provides that FDA, acting by
administrative order, can reclassify the
device into class I or class II on its own
initiative, or in response to a petition
from the manufacturer or importer of
the device. To change the classification
of the device, the proposed new class
must have sufficient regulatory controls
to provide a reasonable assurance of the
E:\FR\FM\04NOR1.SGM
04NOR1
]]>Agencies
[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Rules and Regulations]
[Pages 66544-66545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23852]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2022-0436; Airspace Docket No. 22-ASW-1]
RIN 2120-AA66
Amendment and Establishment of Air Traffic Service (ATS) Routes;
South Central United States
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This action corrects a final rule published by the FAA in the
Federal Register on October 27, 2022, that amends VHF Omnidirectional
Range (VOR) Federal airways V-198, V-212, V-556, and V-558; amends Area
Navigation (RNAV) route T-256; and establishes RNAV route T-466. In the
new RNAV route T-466, the final rule identified the CHILD, TX, route
point as a waypoint (WP) and the SEEDS, TX, route point as a Fix, in
error. This action makes editorial corrections to the reference of the
CHILD, TX, WP to change it to be reflected as a Fix and to the SEEDS,
TX, Fix to change it to be reflected as a WP. These corrections are
necessary to match the FAA National Airspace System Resource (NASR)
database information.
DATES: Effective date 0901 UTC, December 29, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.
ADDRESSES: FAA Order 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.
FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.
SUPPLEMENTARY INFORMATION:
History
The FAA published a final rule in the Federal Register (87 FR
65011; October 27, 2022), amending VOR Federal airways V-198, V-212, V-
556, and V-558; amending RNAV route T-256; and establishing RNAV route
T-466. Subsequent to publication, the FAA determined that the CHILD,
TX, route point was inadvertently identified as a WP and the SEEDS, TX,
route point was inadvertently identified as a Fix, in error. The
correct route point references are the CHILD, TX, Fix and the SEEDS,
TX, WP. This rule corrects those errors by changing the reference of
the CHILD, TX, WP to the CHILD, TX, Fix; and the reference of the
SEEDS, TX, Fix to the SEEDS, TX, WP.
These are editorial changes only to match the FAA NASR database
information and do not alter the alignment of the affected T-466 route.
United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11G, dated August 19, 2022, and effective
September 15, 2022, which is incorporated by reference in 14 CFR 71.1.
The RNAV T-route listed in this document will be published subsequently
in FAA Order JO 7400.11.
Correction to Final Rule
Accordingly, pursuant to the authority delegated to me, references
to the CHILD, TX, WP and to the SEEDS, TX, Fix that are reflected in
Docket No. FAA-2022-0436, as published in the Federal Register of
October 27, 2022 (87 FR 65011), FR Doc. 2022-22164, are corrected as
follows:
0
1. On pages 65012 and 65013, correct the table for T-466 San Angelo, TX
(SJT) to Sabine Pass, TX (SBI) [New] to read:
T-466 San Angelo, TX (SJT) to Sabine Pass, TX (SBI) [New]
San Angelo, TX (SJT) VORTAC (Lat. 31[deg]22'29.84'' N, long. 100[deg]27'17.53'' W)
CHILD, TX FIX (Lat. 31[deg]03'41.17'' N, long. 100[deg]27'40.62'' W)
Junction, TX (JCT) VORTAC (Lat. 30[deg]35'52.88'' N, long. 099[deg]49'02.93'' W)
[[Page 66545]]
BETTI, TX FIX (Lat. 29[deg]57'54.97'' N, long. 098[deg]03'23.98'' W)
MARCS, TX FIX (Lat. 29[deg]53'52.04'' N, long. 097[deg]51'40.70'' W)
SEEDS, TX WP (Lat. 29[deg]39'31.94'' N, long. 097[deg]14'58.66'' W)
LDRET, TX WP (Lat. 29[deg]39'44.93'' N, long. 096[deg]19'00.96'' W)
KEEDS, TX WP (Lat. 29[deg]21'59.49'' N, long. 095[deg]36'48.98'' W)
Scholes, TX (VUH) VOR/DME (Lat. 29[deg]16'09.60'' N, long. 094[deg]52'03.81'' W)
Sabine Pass, TX (SBI) VOR/DME (Lat. 29[deg]41'12.19'' N, long. 094[deg]02'16.72'' W)
* * * * *
Issued in Washington, DC, on October 28, 2022.
Mark E. Gauch,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-23852 Filed 11-3-22; 8:45 am]
BILLING CODE 4910-13-P
