Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction, 46900-46901 [2017-21659]
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Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations
geographic lat./long. coordinate for the
point located in the northeast corner of
R–2603 has been relocated, so as to not
impact use of the airway.
The Rule
The FAA is amending Title 14 Code
of Federal Regulations (14 CFR) part 73
to establish a new restricted area R–
2603 at the Pinon Canyon Maneuver
Site, near Trinidad, CO. The FAA is also
incorporating the restricted area updates
noted in the Differences from the NPRM
section. The FAA is taking this action to
ensure realistic Army training which
provides increased ground-to-air, air-toground, and air-to-air battle space to
increase training capacity and relieve
training congestion at Fort Carson. The
changes from what was proposed in the
NPRM are as follows:
R–2603: The geographic coordinate
proposed as ‘‘lat. 37°38′33″ N., long.
103°35′11″ W.’’ in the boundaries
description is deleted and replaced by a
point identified as ‘‘lat. 37°38′28″ N.,
long. 103°42′40″ W.’’ The legal
description of R–2603 was changed
from a counter clockwise direction to a
clockwise direction.
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Regulatory Notices and Analyses
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 Department of
Transportation (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. Since this is a routine
matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
Environmental Review
The FAA has determined that this
action of establishing restricted area R–
2603 within the existing Fort Carson,
CO, Pinon Canyon Maneuver Site
(PCMS), near Trinidad, CO, qualifies for
FAA adoption in accordance with FAA
Order 1050.1F, paragraphs 8–2 and 9–2,
Adoption of Other Agencies’ National
Environmental Policy Act Documents,
and Written Re-evaluations, and
7400.2L, paragraph 32–2–3. The
purpose of creating and utilizing the
Restricted Area (RA) is to allow for
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increased ground-to-air, air-to-ground,
and air-to-air battle space to increase
training capacity and relieve training
congestion at Fort Carson. The FAA,
after conducting an independent review
and evaluation of the United States
Army’s Final Environmental Impact
Statement of the Pinon Canyon
Maneuver Site Training and Operations
(EIS) and Record of Decision (ROD) for
Restricted Area R–2603 at Fort Carson,
CO, has determined that the Army’s EIS
and its supporting documentation
adequately assesses and discloses the
environmental impacts of the Proposed
Action including evaluation of the
establishment of airspace for restricted
airspace area R–2603. In March 2013,
the Army Environmental Command and
Fort Carson released the EIS regarding
the Pinon Canyon Maneuver Site
(PCMS) Training and Operations located
in Colorado. On May 1, 2015, the Army
issued their ROD. The Army prepared
its EIS and ROD in compliance with
NEPA and Army-specific environmental
regulations (32 CFR part 651).
Based on the evaluation for potential
environmental impact in the Army’s
EIS, the FAA, as the Cooperating
Agency for the Army’s proposed action,
concluded that adoption of the Army’s
EIS evaluating the proposed
establishment of R–2603 is authorized
in accordance with 40 CFR 1506.3,
Adoption. Accordingly, FAA adopts the
Army’s EIS and takes full responsibility
for the scope and content that address
the FAA’s airspace establishment
action.
List of Subjects in 14 CFR Part 73
Airspace, Prohibited areas, Restricted
areas.
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 73 as follows:
PART 73—SPECIAL USE AIRSPACE
1. The authority citation for part 73
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 73.26
[Amended]
2. Section 73.26 is amended as
follows:
*
*
*
*
*
■
R–2603 Fort Carson, CO [New]
Boundaries: Beginning lat. 37°22′30″ N.,
long. 104°04′47″ W.; to lat. 37°32′27″ N.,
long. 104°06′32″ W.; to lat. 37°32′27″ N.,
long. 104°02′15″ W.; to lat. 37°33′21″ N.,
long. 103°57′55″ W.; to lat. 37°35′59″ N.,
long. 103°57′50″ W.; to lat. 37°35′57″ N.,
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long. 103°54′40″ W.; to lat. 37°38′10″ N.,
long. 103°48′47″ W.; to lat. 37°38′32″ N.,
long. 103°48′43″ W.; to lat. 37°38′28″ N.,
long. 103°42′40″ W.; to lat. 37°32′46″ N.,
long. 103°42′46″ W.; to lat. 37°21′10″ N.,
long. 103°54′41″ W.; to lat. 37°21′15″ N.,
long. 104°02′35″ W.; thence to the point of
beginning.
Designated altitudes: Surface to but not
including 10,000 feet Mean Sea Level (MSL).
Time of designation: By NOTAM 24 hours
in advance.
Controlling agency: FAA, Denver ARTCC.
Using agency: Commander, U.S. Army,
Fort Carson, CO.
Issued in Washington, DC, on October 3,
2017.
Scott M. Rosenbloom,
Acting Manager, Airspace Policy Group.
[FR Doc. 2017–21794 Filed 10–6–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2017–N–1620]
Medical Devices; Cardiovascular
Devices; Classification of the
Adjunctive Cardiovascular Status
Indicator; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order; correction.
The Food and Drug
Administration (FDA) is correcting a
final order entitled ‘‘Medical Devices;
Cardiovascular Devices; Classification of
the Adjunctive Cardiovascular Status
Indicator’’ that appeared in the Federal
Register of July 28, 2017. The final order
was published with an incorrect
statement in the preamble about
whether FDA planned to exempt the
device from premarket notification
requirements. This document corrects
that error.
DATES: Effective October 10, 2017.
FOR FURTHER INFORMATION CONTACT:
Nathalie Yarkony, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1254, Silver Spring,
MD 20993–0002, Nathalie.yarkony@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 28, 2017 (82 FR
35065), FDA published the final order
‘‘Medical Devices; Cardiovascular
Devices; Classification of the Adjunctive
Cardiovascular Status Indicator.’’ The
final order published with an incorrect
statement in the preamble about
SUMMARY:
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Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations
whether FDA planned to exempt the
device from premarket notification
requirements under section 510(k) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360(k)).
Correction
In the Federal Register of July 28,
2017, in FR Doc. 2017–15901, the
following correction is made:
On page 35066, at the bottom of the
page below table 1, beginning in the first
column, the third paragraph is corrected
as follows:
‘‘Section 510(m) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
requirements under section 510(k), if
FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. For this type
of device, FDA has determined that
premarket notification is necessary to
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, this device type is not
exempt from premarket notification
requirements. Persons who intend to
market this type of device must submit
to FDA a premarket notification, prior to
marketing the device, which contains
information about the adjunctive
cardiovascular status indicator they
intend to market.’’
Dated: October 2, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–21659 Filed 10–6–17; 8:45 am]
is intended to restrict vessel traffic on
the Atlantic Intracoastal Waterway to
protect mariners, vessels, and training
exercise participants from the hazards
associated with military training
operations. Entry of vessels or persons
into this safety zone is prohibited unless
specifically authorized by the Captain of
the Port (COTP) North Carolina or a
designated representative.
DATES: This rule is effective from
October 10, 2017 through October 30,
2017.
To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2017–
0792 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, contact
Petty Officer Matthew Tyson,
Waterways Management Division, U.S.
Coast Guard Sector North Carolina,
Wilmington, NC; telephone: 910–772–
2221, email: Matthew.I.Tyson@uscg.mil.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
ICW IntraCoastal Waterway
BILLING CODE 4164–01–P
II. Background Information and
Regulatory History
DEPARTMENT OF HOMELAND
SECURITY
The Coast Guard is issuing this
temporary rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule. The Coast
Guard was notified of the final dates
needed for this rule on August 17, 2017.
It is impracticable and contrary to the
public interest to delay this action.
Waiting for a comment period to run
would inhibit the Coast Guards’ ability
to protect the public and participants
from the dangers associated with the
military exercises scheduled from
October 10 through October 30, 2017.
Coast Guard
33 CFR Part 165
[Docket Number USCG–2017–0792]
RIN 1625–AA00
Safety Zone; Atlantic Intracoastal
Waterway, Camp Lejeune, NC
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone on
the Atlantic Intracoastal Waterway in
Camp Lejeune, North Carolina in
support of military training exercises.
This temporary safety zone is intended
to restrict vessel traffic from a portion of
the Atlantic Intracoastal Waterway
between Mile Hammock Bay and
Onslow Beach Swing Bridge during
military training operations. This action
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SUMMARY:
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46901
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this temporary rule effective less
than 30 days after publication in the
Federal Register. Immediate
implementation is required to protect
the public and participants from the
dangers associated with the military
training exercises.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 33 U.S.C. 1231. The
COTP North Carolina has determined
that potential hazards associated with
the military exercises scheduled from
October 10 through October 30, 2017, is
a safety concern for mariners and
participants. The military training
exercises involve building temporary
bridges, crossing with amphibious
vehicles, and other military operations
on the ICW. These military training
activities will block the waterway in a
manner that restricts all vessel
navigation and movement within this
segment of the ICW. This rule is
necessary to protect persons and vessels
from the potential hazards associated
with the military training exercises.
IV. Discussion of the Rule
The safety zone will be enforced on
the following dates and times in October
2017:
Date
Time
10th–12th .....
8 a.m. through 11 a.m. and 1
p.m. through 4 p.m.
9 a.m. through 12 p.m. and 1
p.m. through 4 p.m.
8 a.m. through 12 p.m.
8 a.m. through 12 p.m. and 1
p.m. through 4 p.m.
9 a.m. through 1 p.m. and 2
p.m. through 5 p.m.
7 a.m. through 5 p.m.
7 a.m. through 11 a.m.
13th ..............
18th ..............
24th ..............
25th–26th .....
27th–28th .....
29th–30th .....
The safety zone will include all
navigable waters of the ICW from Mile
Hammock Bay, approximate position
34°32′46″ N., 77°19′17″ W., to Onslow
Beach Swing Bridge approximate
position 34°34′25″ N., 77°16′14″ W.
(NAD 1983), an approximately four mile
portion of the ICW. The duration of this
zone is intended to protect mariners
from the hazards associated with
military training operations. No vessel
or person will be permitted to enter the
safety zone unless specifically
authorized by the Captain of the Port
North Carolina or a designated
representative. The regulatory text
appears at the end of this document.
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]]>Agencies
[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Rules and Regulations]
[Pages 46900-46901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21659]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2017-N-1620]
Medical Devices; Cardiovascular Devices; Classification of the
Adjunctive Cardiovascular Status Indicator; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
order entitled ``Medical Devices; Cardiovascular Devices;
Classification of the Adjunctive Cardiovascular Status Indicator'' that
appeared in the Federal Register of July 28, 2017. The final order was
published with an incorrect statement in the preamble about whether FDA
planned to exempt the device from premarket notification requirements.
This document corrects that error.
DATES: Effective October 10, 2017.
FOR FURTHER INFORMATION CONTACT: Nathalie Yarkony, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002,
Nathalie.yarkony@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2017 (82
FR 35065), FDA published the final order ``Medical Devices;
Cardiovascular Devices; Classification of the Adjunctive Cardiovascular
Status Indicator.'' The final order published with an incorrect
statement in the preamble about
[[Page 46901]]
whether FDA planned to exempt the device from premarket notification
requirements under section 510(k) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)).
Correction
In the Federal Register of July 28, 2017, in FR Doc. 2017-15901,
the following correction is made:
On page 35066, at the bottom of the page below table 1, beginning
in the first column, the third paragraph is corrected as follows:
``Section 510(m) of the FD&C Act provides that FDA may exempt a
class II device from the premarket notification requirements under
section 510(k), if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the adjunctive cardiovascular status
indicator they intend to market.''
Dated: October 2, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21659 Filed 10-6-17; 8:45 am]
BILLING CODE 4164-01-P
