Amendment Class D and Class E Airspace; Ardmore, OK, 68395-68396 [2021-26187]
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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
68395
TABLE 14—HEATING MODE TEST CONDITIONS FOR UNITS HAVING A VARIABLE-SPEED COMPRESSOR—Continued
Air entering
indoor unit
temperature
(°F)
Test description
Dry bulb
H1N test (required,
steady).
H1C1 test (optional, cyclic).
H22 test (optional) .......
H2V test (required) ......
H32 test (required,
steady).
H42 test (optional,
steady).
Air entering
outdoor unit
temperature
(°F)
Wet bulb
Dry bulb
Compressor speed
Heating air volume rate
Wet bulb
70
60(max) .........
47
43 ................
Heating Full 5 ..............
Heating Full-Load.3
70
60(max) .........
47
43 ................
Heating Minimum .......
(2).
70
70
70
60(max) .........
60(max) .........
60(max) .........
35
35
17
33 ................
33 ................
15 ................
Heating Full 4 ..............
Heating Intermediate ..
Heating Full 4 ..............
Heating Full-Load.3
Heating Intermediate.6
Heating Full-Load.3
70
60(max) .........
5
3(max) ...........
Heating Full 7 ..............
Heating Full-Load.3
1 Defined
in section 3.1.4.5 of this appendix.
the airflow nozzle(s) static pressure difference or velocity pressure during an ON period at the same pressure or velocity as measured during the H11 test.
3 Defined in section 3.1.4.4 of this appendix.
4 Maximum speed that the system controls would operate the compressor in normal operation in 17 °F ambient temperature. The H1 test is
2
not needed if the H1N test uses this same compressor speed.
5 Maximum speed that the system controls would operate the compressor in normal operation in 47 °F ambient temperature.
6 Defined in section 3.1.4.6 of this appendix.
7 Maximum speed that the system controls would operate the compressor in normal operation at 5 °F ambient temperature.
2 Maintain
FARM CREDIT ADMINISTRATION
Jennifer A. Cohn, Cohnj@fca.gov,
Assistant General Counsel, Office of
General Counsel, Farm Credit
Administration, McLean, VA 22102–
5090, (703) 883–4020, TTY (703) 883–
4056.
12 CFR Parts 614, 615, 620 and 628
SUPPLEMENTARY INFORMATION:
*
*
*
*
*
[FR Doc. 2021–25539 Filed 12–1–21; 8:45 am]
BILLING CODE 6450–01–P
RIN 3052–AD27
Regulatory Capital Rules: Tier 1/Tier 2
Framework
Farm Credit Administration.
ACTION: Notification of effective date.
AGENCY:
The Farm Credit
Administration (FCA) issued a final rule
to amend the regulatory capital
requirements for Farm Credit System
(System or FCS) institutions. The
amendments clarified certain provisions
in the Tier 1/Tier 2 Capital Framework
and codified the guidance provided in
an FCA bookletter.
DATES: Effective date: The final rule
amending 12 CFR parts 614, 615, 620
and 628 published on October 1, 2021
(86 FR 54347), is effective on January 1,
2022.
FOR FURTHER INFORMATION CONTACT:
Technical information: Jeremy R.
Edelstein, EdelsteinJ@fca.gov, Associate
Director or Clayton D. Milburn,
MilburnC@fca.gov, Senior Financial
Analyst, Finance and Capital Markets
Team, Office of Regulatory Policy, Farm
Credit Administration, McLean, VA
22102–5090, (703) 883–4414, TTY (703)
883–4056 or ORPMailbox@fca.gov; or
Legal information: Rebecca S. Orlich,
Orlichr@fca.gov, Senior Counsel, or
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
16:32 Dec 01, 2021
Jkt 256001
On
October 1, 2021, FCA issued a final rule
to amend the regulatory capital
requirements for System institutions.
The amendments clarified provisions in
the Tier 1/Tier 2 Capital Framework,
codified the guidance provided in FCA
Bookletter BL–068, reduced
administrative burden, and amended
definitions pertaining to qualified
financial contracts. In accordance with
12 U.S.C. 2252(c)(1), the final rule
provided an effective date of the later to
occur of January 1, 2022 or 30 days after
the date of rule’s publication in the
Federal Register during which either or
both Houses of Congress are in session.
Based on the records of the sessions of
Congress, the effective date of the
regulation is January 1, 2022.
Dated: November 29, 2021.
Ashley Waldron,
Secretary, Farm Credit Administration.
[FR Doc. 2021–26173 Filed 12–1–21; 8:45 am]
BILLING CODE 6705–01–P
PO 00000
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2021–0674; Airspace
Docket No. 21–ASW–14]
RIN 2120–AA66
Amendment Class D and Class E
Airspace; Ardmore, OK
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; correction.
AGENCY:
This action corrects
typographic errors in the final rule
published in the Federal Register on
October 26, 2021, amending the Class D
and Class E airspace at Ardmore, OK.
DATES: Effective date 0901 UTC, January
27, 2022. The Director of the Federal
Register approves this incorporation by
reference action under Title 1 CFR part
51, subject to the annual revision of
FAA Order JO 7400.11 and publication
of conforming amendments.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Claypool, Federal Aviation
Administration, Operations Support
Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX
76177; telephone (817) 222–5711.
SUPPLEMENTARY INFORMATION:
SUMMARY:
History
The FAA published a final rule in the
Federal Register (86 FR 59015; October
26, 2021) for FR Doc. 2021–23008
amending the Class D and Class E
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02DER1
68396
Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
airspace at Ardmore, OK. Subsequent to
publication, the FAA identified
typographic errors that occurred when
the notice to proposed rulemaking was
transposed to the final rule in the Class
E Airspace Areas Designated as an
Extension to a Class D or Class E Surface
Area and Class E airspace extending
upward from 700 feet above the surface
airspace legal descriptions. This action
corrects those errors.
Class D and Class E airspace
designations are published in paragraph
5000, 6002, and 6005, respectively, of
FAA Order JO 7400.11F dated August
10, 2021, and effective September 15,
2021, which is incorporated by
reference in 14 CFR 71.1. The Class D
and Class E airspace designations listed
in this document will be subsequently
published in FAA Order JO 7400.11.
Correction to Final Rule
Accordingly, pursuant to the
authority delegated to me, Amendment
Class D and Class E Airspace; Ardmore,
OK, published in the Federal Register of
October 26, 2021 (86 FR 59015), FR Doc.
2021–23008, is corrected as follows:
71.1
[Amended]
On page 59016, column 2, line 41,
amend to read, ‘‘Airport extending from
the 4.3-mile radius of’’.
■ On page 59016, column 2, line 60,
amend to read, ‘‘That airspace extending
upward from’’.
■
Issued in Fort Worth, Texas, on November
29, 2021.
Martin A. Skinner,
Acting Manager, Operations Support Group
ATO Central Service Center.
[FR Doc. 2021–26187 Filed 12–1–21; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. FDA–2021–N–0622]
Medical Devices; Anesthesiology
Devices; Classification of the
Isocapnic Ventilation Device
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
lotter on DSK11XQN23PROD with RULES1
AGENCY:
The Food and Drug
Administration (FDA or we) is
classifying the isocapnic ventilation
device into class II (special controls).
The special controls that apply to the
SUMMARY:
VerDate Sep<11>2014
16:00 Dec 01, 2021
Jkt 256001
device type are identified in this order
and will be part of the codified language
for the isocapnic ventilation device’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
2, 2021. The classification was
applicable on March 14, 2019.
FOR FURTHER INFORMATION CONTACT:
Todd Courtney, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1216, Silver Spring,
MD 20993–0002, 301–796–6371,
Todd.Courtney@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
isocapnic ventilation device as class II
(special controls), which we have
determined will provide a reasonable
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
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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
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 in order
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 August 18, 2017, Thornhill
Research, Inc. submitted a request for
De Novo classification of the ClearMate.
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
E:\FR\FM\02DER1.SGM
02DER1
Agencies
[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Rules and Regulations]
[Pages 68395-68396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26187]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2021-0674; Airspace Docket No. 21-ASW-14]
RIN 2120-AA66
Amendment Class D and Class E Airspace; Ardmore, OK
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This action corrects typographic errors in the final rule
published in the Federal Register on October 26, 2021, amending the
Class D and Class E airspace at Ardmore, OK.
DATES: Effective date 0901 UTC, January 27, 2022. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 CFR part 51, subject to the annual revision of FAA Order JO
7400.11 and publication of conforming amendments.
FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
SUPPLEMENTARY INFORMATION:
History
The FAA published a final rule in the Federal Register (86 FR
59015; October 26, 2021) for FR Doc. 2021-23008 amending the Class D
and Class E
[[Page 68396]]
airspace at Ardmore, OK. Subsequent to publication, the FAA identified
typographic errors that occurred when the notice to proposed rulemaking
was transposed to the final rule in the Class E Airspace Areas
Designated as an Extension to a Class D or Class E Surface Area and
Class E airspace extending upward from 700 feet above the surface
airspace legal descriptions. This action corrects those errors.
Class D and Class E airspace designations are published in
paragraph 5000, 6002, and 6005, respectively, of FAA Order JO 7400.11F
dated August 10, 2021, and effective September 15, 2021, which is
incorporated by reference in 14 CFR 71.1. The Class D and Class E
airspace designations listed in this document will be subsequently
published in FAA Order JO 7400.11.
Correction to Final Rule
Accordingly, pursuant to the authority delegated to me, Amendment
Class D and Class E Airspace; Ardmore, OK, published in the Federal
Register of October 26, 2021 (86 FR 59015), FR Doc. 2021-23008, is
corrected as follows:
71.1 [Amended]
0
On page 59016, column 2, line 41, amend to read, ``Airport extending
from the 4.3-mile radius of''.
0
On page 59016, column 2, line 60, amend to read, ``That airspace
extending upward from''.
Issued in Fort Worth, Texas, on November 29, 2021.
Martin A. Skinner,
Acting Manager, Operations Support Group ATO Central Service Center.
[FR Doc. 2021-26187 Filed 12-1-21; 8:45 am]
BILLING CODE 4910-13-P