46900 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. 

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 

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., 

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] 

BILLING CODE 4910–13–P 

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 


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Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–0792] 

RIN 1625–AA00 

Safety Zone; Atlantic Intracoastal 

Waterway, Camp Lejeune, NC 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: 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 

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. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

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: 

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 

II. Background Information and 

Regulatory History 

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. 

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. 

13th .............. 9 a.m. through 12 p.m. and 1 

p.m. through 4 p.m. 

18th .............. 8 a.m. through 12 p.m. 

24th .............. 8 a.m. through 12 p.m. and 1 

p.m. through 4 p.m. 

25th–26th ..... 9 a.m. through 1 p.m. and 2 

p.m. through 5 p.m. 

27th–28th ..... 7 a.m. through 5 p.m. 

29th–30th ..... 7 a.m. through 11 a.m. 

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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