52992 Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Rules and Regulations 

Group, Central Service Center, 10101 

Hillwood Parkway, Fort Worth, TX, 

76177; telephone (817) 222–5857. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part, A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it establishes 

controlled airspace at Park River-W C 

Skjerven Field, Park River, ND. 

History 

On May 24, 2016, the FAA published 

in the Federal Register a notice of 

proposed rulemaking (NPRM) to 

establish Class E Airspace in the Park 

River, ND area. (81 FR 32679) FAA– 

2016–5856. Interested parties were 

invited to participate in this rulemaking 

effort by submitting written comments 

on the proposal to the FAA. No 

comments were received. 

Class E airspace designations are 

published in paragraph 6005 of FAA 

Order 7400.9Z dated August 6, 2015, 

and effective September 15, 2015, which 

is incorporated by reference in 14 CFR 

part 71.1. The Class E airspace 

designations listed in this document 

will be published subsequently in the 

Order. 

Availability and Summary of 

Documents for Incorporation by 

Reference 

This document amends FAA Order 

7400.9Z, airspace Designations and 

Reporting Points, dated August 6, 2015, 

and effective September 15, 2015. FAA 

Order 7400.9Z is publicly available as 

listed in the ADDRESSES section of this 

document. FAA Order 7400.9Z lists 

Class A, B, C, D, and E airspace areas, 

air traffic service routes, and reporting 

points. 

The Rule 

This amendment to Title 14, Code of 

Federal Regulations (14 CFR) part 71 

establishes Class E airspace extending 

upward from 700 feet above the surface 

within a 7-mile radius of Park River-W 

C Skjerven Field, Park River, ND, to 

accommodate new standard instrument 

approach procedures. Controlled 

airspace is needed for the safety and 

management of IFR operations at the 

airport. Additionally, this corrects the 

airport name to coordinate with the 

NASR, previously listed in the NPRM 

header and legal description as Park 

River Airport-WC Skjerven Field to Park 

River-W C Skjerven Field. 

Class E airspace areas are published 

in Section 6005 of FAA Order 7400.9Z, 

dated August 6, 2015, and effective 

September 15, 2015, which is 

incorporated by reference in 14 CFR 

71.1. The Class E airspace designations 

listed in this document will be 

published subsequently in the Order. 

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, is non-controversial and 

unlikely to result in adverse or negative 

comments. 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. 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 qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1F, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 5–6.5a. This airspace action 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exists 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for Part 71 

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. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9Z, 

Airspace Designations and Reporting 

Points, dated August 6, 2015, effective 

September 15, 2015, is amended as 

follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AGL ND E5 Park River, ND [New] 

Park River–W C Skjerven Field 

(Lat. 48°23′39′′ N., long. 097°46′51′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 7-mile radius 

of Park River–W C Skjerven Field. 

Issued in Fort Worth, TX, on July 28, 2016. 

Walter Tweedy, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2016–18772 Filed 8–10–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2016–4629; Airspace 

Docket No. 16–AGL–8] 

Amendment of Class E Airspace for 

the Following Michigan Towns; Alma, 

MI; Bellaire, MI; Cadillac, MI; 

Drummond Island, MI; Gladwin, MI; 

Holland, MI; and Three Rivers, MI 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action modifies Class E 

airspace extending upward from 700 

feet above the surface at Gratiot 

Community Airport, Alma, MI; Antrim 

County Airport, Bellaire, MI; Wexford 

County Airport, Cadillac, MI; 

Drummond Island Airport, Drummond 

Island, MI; Charles C. Zettel Memorial 

Airport, Gladwin, MI; Park Township 

Airport and West Michigan Regional 

Airport, Holland, MI; and Three Rivers 

Municipal Dr. Haines Airport, Three 

Rivers, MI. Decommissioning of nondirectional radio beacons (NDB), 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Rules and Regulations 52993 

cancellation of NDB approaches, or 

implementation of area navigation 

(RNAV) procedures have made this 

action necessary for the safety and 

management of Instrument Flight Rules 

(IFR) operations at the above airports. 

This action also updates the geographic 

coordinates of Three Rivers Municipal 

Dr. Haines Airport, and the name 

change of West Michigan Regional 

Airport (formerly Tulip City Airport) to 

coincide with the FAA’s aeronautical 

database. 

DATES: Effective 0901 UTC, November 

10, 2016. The Director of the Federal 

Register approves this incorporation by 

reference action under Title 1, Code of 

Federal Regulations, part 51, subject to 

the annual revision of FAA Order 

7400.9 and publication of conforming 

amendments. 

ADDRESSES: FAA Order 7400.9Z, 

Airspace Designations and Reporting 

Points, and subsequent amendments can 

be viewed online at http://www.faa.gov/ 

air_traffic/publications/. For further 

information, you can contact the 

Airspace Policy Group, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone: 202–267–8783. The Order is 

also available for inspection at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of FAA 

Order 7400.9Z at NARA, call 202–741– 

6030, or go to http://www.archives.gov/ 

federal_register/code_of_federalregulations/ibr_locations.html. 

FAA Order 7400.9, Airspace 

Designations and Reporting Points, is 

published yearly and effective on 

September 15. 

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: 

Authority for This Rulemaking 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it amends 

Class E airspace at Gratiot Community 

Airport, Alma, MI; Antrim County 

Airport, Bellaire, MI; Wexford County 

Airport, Cadillac, MI; Drummond Island 

Airport, Drummond Island, MI; Charles 

C. Zettel Memorial Airport, Gladwin, 

MI; Park Township Airport and West 

Michigan Regional Airport, Holland, MI; 

and Three Rivers Municipal Dr. Haines 

Airport, Three Rivers, MI. 

History 

On May 3, 2016, the FAA published 

in the Federal Register a notice of 

proposed rulemaking (NPRM) to modify 

Class E airspace at Gratiot Community 

Airport, Alma, MI; Antrim County 

Airport, Bellaire, MI; Wexford County 

Airport, Cadillac, MI; Drummond Island 

Airport, Drummond Island, MI; Charles 

C. Zettel Memorial Airport, Gladwin, 

MI; Park Township Airport and West 

Michigan Regional Airport, Holland, MI; 

and Three Rivers Municipal Dr. Haines 

Airport, Three Rivers, MI (81 FR 26501) 

Docket No. FAA–2016–4629. Interested 

parties were invited to participate in 

this rulemaking effort by submitting 

written comments on the proposal to the 

FAA. No comments were received. 

Class E airspace designations are 

published in paragraph 6005 of FAA 

Order 7400.9Z, dated August 6, 2015, 

and effective September 15, 2015, which 

is incorporated by reference in 14 CFR 

part 71.1. The Class E airspace 

designation listed in this document will 

be published subsequently in the Order. 

Availability and Summary of 

Documents for Incorporation by 

Reference 

This document amends FAA Order 

7400.9Z, Airspace Designations and 

Reporting Points, dated August 6, 2015, 

and effective September 15, 2015. FAA 

Order 7400.9Z is publicly available as 

listed in the ADDRESSES section of this 

document. FAA Order 7400.9Z lists 

Class A, B, C, D, and E airspace areas, 

air traffic service routes, and reporting 

points. 

The Rule 

This amendment to Title 14, Code of 

Federal Regulations (14 CFR) part 71 

modifies Class E airspace extending 

upward from 700 feet above the surface 

at the following airports: 

Within a 6.5-mile radius of Gratiot 

Community Airport, Alma, MI; 

Within a 6.5-mile radius of Antrim 

County Airport, Bellaire, MI, with a 

segment extending from the 6.5-mile 

radius to 6.9 miles south of the airport; 

Within a 6.7-mile radius of Wexford 

County Airport, Cadillac, MI; 

Within a 6.5-mile radius of 

Drummond Island Airport, Drummond 

Island, MI, with a segment extending 

from the 6.5-mile radius to 8.5 miles 

east of the airport; 

Within a 6.5-mile radius of Charles C. 

Zettel Memorial Airport, Gladwin, MI; 

Within a 6.5-mile radius of West 

Michigan Regional Airport (formerly 

Tulip City Airport), Holland, MI; Park 

Township Airport is removed as it no 

longer has instrument procedures and 

no longer requires Class E airspace; and 

Within a 6.4 mile radius of Three 

Rivers Municipal Dr. Haines Airport, 

Three Rivers, MI, and updates the 

geographic coordinates of this airport to 

coincide with the FAAs aeronautical 

database. 

These airspace reconfigurations are 

necessary due to the decommissioning 

of NDBs, cancellation of NDB 

approaches, or implementation of 

RNAV procedures at the above airports. 

Controlled airspace is necessary for the 

safety and management of the standard 

instrument approach procedures for IFR 

operations at the airports. 

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, is non-controversial and 

unlikely to result in adverse or negative 

comments. 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. 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 qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1F, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 5–6.5.a. This airspace action 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 


sradovich on DSK3GMQ082PROD with RULES
52994 Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Rules and Regulations 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 

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. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9Z, 

Airspace Designations and Reporting 

Points, dated August 6, 2015, and 

effective September 15, 2015, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AGL MI E5 Alma, MI [Amended] 

Alma, Gratiot Community Airport, MI 

(Lat. 43°19′20′′ N., long. 84°41′17′′ W.) 

Mount Pleasant VOR/DME 

(Lat. 43°37′22′′ N., long. 84°44′14′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of Gratiot Community Airport, and 

within 2.0 miles either side of a 270° bearing 

from the airport extending from the 6.5-mile 

radius to 10.1 miles west of the airport, and 

within 1.5 miles either side of the Mount 

Pleasant VOR/DME 178° radial extending 

from the 6.5-mile radius to 10.3 miles north 

of the airport. 

* * * * * 

AGL MI E5 Bellaire, MI [Amended] 

Bellaire, Antrim County Airport, MI 

(Lat. 44°59′19′′ N., long. 85°11′54′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of Antrim County Airport, and within 

1.9 miles each side of the 197° bearing from 

the airport extending from the 6.5-mile 

radius to 6.9 miles south of the airport. 

* * * * * 

AGL MI E5 Cadillac, MI [Amended] 

Cadillac, Wexford County Airport, MI 

(Lat. 44°16′31′′ N., long. 85°25′08′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.7-mile 

radius of the Wexford County Airport. 

* * * * * 

AGL MI E5 Drummond Island, MI 

[Amended] 

Drummond Island Airport, MI 

(Lat. 46° 00′34′′ N., long. 83° 44′38′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of Drummond Island Airport, and 

within 4 miles each side of the 072° bearing 

from the airport extending from the 6.5-mile 

radius to 8.5 miles east of the airport; that 

airspace extending upward from 1,200 feet 

above the surface bounded by long. 83° 

57’00’’ W., on the west; long. 83° 26’00’’ W., 

on the east; lat. 46° 05’00’’ N., on the north; 

and lat. 45° 45’00’’ N., on the south, 

excluding that airspace within Canada. 

* * * * * 

AGL MI E5 Gladwin, MI [Amended] 

Charles C. Zettel Memorial Airport, MI 

(Lat. 43°58′14′′ N., long. 84°28′30′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of the Charles C. Zettel Memorial 

Airport. 

* * * * * 

AGL MI E5 Holland, MI [Amended] 

West Michigan Regional Airport, MI 

(Lat. 42°44′34′′ N., long. 86°06′28′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of the West Michigan Regional 

Airport. 

* * * * * 

AGL MI E5 Three Rivers, MI [Amended] 

Three Rivers Municipal Dr Haines Airport, 

MI 

(Lat. 41°57′35′′ N., long. 85°35′35′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.4-mile 

radius of Three Rivers Municipal Dr Haines 

Airport, excluding that airspace within the 

Sturgis, Kirsch Municipal Airport, MI, Class 

E airspace area. 

Issued in Fort Worth, Texas, on July 29, 

2016. 

Walter Tweedy, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2016–18777 Filed 8–10–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 16 

[Docket No. FDA–2016–N–0011] 

Regulatory Hearing Before the Food 

and Drug Administration; General 

Provisions; Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to correct an error in the 

lists of statutory and regulatory 

provisions that provide an opportunity 

for an informal hearing so that the lists 

correctly reference the statutory and 

regulatory provisions that provide such 

an opportunity in connection with a ban 

of a device. This action is being taken 

to align the regulations with the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) and avoid any potential 

confusion the erroneous lists may cause. 

DATES: This rule is effective August 11, 

2016. 

FOR FURTHER INFORMATION CONTACT: Ian 

Ostermiller, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5515, Silver Spring, 

MD 20993–0002, 301–796–5678. 

SUPPLEMENTARY INFORMATION: FDA is 

correcting an error in the regulations 

that identify the statutory and regulatory 

provisions that provide an opportunity 

for a regulatory hearing, also known as 

an informal hearing (§ 16.1 (21 CFR 

16.1)). In the list of statutory provisions 

at § 16.1(b)(1), the Agency is adding a 

reference to subsection (b) of section 

516 of the FD&C Act (21 U.S.C. 360f), 

which provides for a reasonable 

opportunity for an informal hearing 

when FDA proposes a medical device 

ban with a special effective date (21 

U.S.C. 360f(b)(2)). The list of statutory 

provisions does not currently specify 

subsection (b) of section 516 of the 

FD&C Act, and it incorrectly refers to 21 

CFR 895.21(d). An opportunity for a 

hearing is not required under section 

516 of the FD&C Act or part 895 (21 CFR 

part 895) for bans that do not have a 

special effective date. 

Further, the list of regulatory 

provisions at § 16.1(b)(2) does not 

include any reference to part 895. We 

are correcting this by adding a reference 

to § 895.30(c), which provides for an 

opportunity for an informal hearing 

under 21 CFR part 16 when FDA 

proposes a medical device ban with a 

special effective date. These corrections 

will align § 16.1(b) with section 516 of 

the FD&C Act and part 895 to avoid 

confusion regarding when an 

opportunity for hearing is required for a 

device ban. 

Prior to the Safe Medical Devices Act 

of 1990 (SMDA) (Pub. L. 101–629), the 

FD&C Act required the Secretary of 

Health and Human Services to afford an 

opportunity for informal hearings about 

any proposed rule to ban a medical 

device, regardless of effective date. One 

of the SMDA’s provisions removed the 

requirement that FDA provide an 

opportunity for an informal hearing 

when FDA does not establish a special 


sradovich on DSK3GMQ082PROD with RULES