29128 Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2015–5801; Airspace 

Docket No. 15–AGL–18] 

Establishment of Class E Airspace; 

Beach, ND 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action establishes Class 

E airspace extending upward from 700 

feet above the surface at Beach Airport, 

Beach, ND, to accommodate new 

Standard Instrument Approach 

Procedures for the safety and 

management of Instrument Flight Rules 

(IFR) operations at the airport. 

DATES: Effective 0901 UTC, July 21, 

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: 

Rebecca Shelby, Central Service Center, 

Operations Support Group, Federal 

Aviation Administration, Southwest 

Region, 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 

Class E airspace at Beach Airport, Beach 

ND. 

History 

On February 4, 2016, the FAA 

published in the Federal Register a 

notice of proposed rulemaking (NPRM) 

to establish Class E airspace extending 

upward from 700 feet above the surface 

at Beach Airport, Beach, ND. (81 FR 

5948). Docket No. FAA–2015–5801. 

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 

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 action amends Title 14, Code of 

Federal Regulations (14 CFR), Part 71 by 

establishing Class E airspace extending 

upward from 700 feet above the surface 

within an 9-mile radius of Beach 

Airport, Beach, ND, to accommodate 

new Standard Instrument Approach 

Procedures for IFR operations at the 

airport. 

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. 

List 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 ND E5 Beach, ND [New] 

Beach Airport, ND 

(Lat. 46°55′31′′ N., long. 103°58′55′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 

9-mile radius of Beach Airport. 


jstallworth on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations 29129 

Issued in Fort Worth, TX, on April 27, 

2016. 

Vonnie Royal, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2016–10736 Filed 5–10–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 514 

[Docket No. FDA–2012–N–0447] 

RIN 0910–AG45 

Antimicrobial Animal Drug Sales and 

Distribution Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is issuing a 

final rule to require that the sponsor of 

each approved or conditionally 

approved new animal drug product that 

contains an antimicrobial active 

ingredient submit an annual report to us 

on the amount of each such ingredient 

in the drug product that is sold or 

distributed for use in food-producing 

animals, including information on any 

distributor-labeled product. This final 

rule codifies the reporting requirements 

established in section 105 of the Animal 

Drug User Fee Amendments of 2008 

(ADUFA). The final rule also includes 

an additional reporting provision 

intended to enhance our understanding 

of antimicrobial new animal drug sales 

intended for use in specific foodproducing animal species and the 

relationship between such sales and 

antimicrobial resistance. 

DATES: This rule is effective July 11, 

2016. For the applicable compliance 

dates, please see section V, ‘‘Effective 

and Compliance Dates’’ in 

SUPPLEMENTARY INFORMATION. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this final rule into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the final rule: Neal 

Bataller, Center for Veterinary Medicine 

(HFV–210), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–5745, 

Neal.Bataller@fda.hhs.gov. 

With regard to the information 

collection: FDA PRA Staff, Office of 

Operations, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14526, Silver Spring, MD 20993– 

0002, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Final Rule 

B. Summary of the Major Provisions of the 

Final Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Background 

A. Need for the Regulation/History of the 

Rulemaking 

B. Summary of Comments to the Proposed 

Rule 

C. General Overview of the Final Rule 

III. Legal Authority 

IV. Comments on the Proposed Rule and FDA 

Response 

A. Introduction 

B. Description of General Comments and 

FDA Response 

C. Comments on our Legal Authority and 

FDA Response 

D. Specific Comments and FDA Response 

V. Effective and Compliance Dates 

VI. Economic Analysis of Impacts 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. References 

I. Executive Summary 

A. Purpose of the Final Rule 

The purpose of this rulemaking is to 

change the way we collect and report 

information related to the distribution 

and sale of approved or conditionally 

approved antimicrobial new animal 

drug products for use in food-producing 

animals. 

Sponsors of approved or conditionally 

approved applications for new animal 

drugs containing an antimicrobial active 

ingredient are required by section 512 of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 360b), as 

amended by section 105 of ADUFA 

(ADUFA 105) (Title I of Pub. L. 110– 

316), to submit to us an annual report 

on the amount of each such ingredient 

in the drug that is sold or distributed for 

use in food-producing animals. We are 

also required by ADUFA 105 to publish 

annual summary reports of the data we 

receive from animal drug sponsors. In 

accordance with the law, sponsors of 

the affected antimicrobial new animal 

drug products began submitting their 

sales and distribution data to us on an 

annual basis, and we have published 

summaries of such data for each 

calendar year beginning with 2009. 

Since that time, we have published two 

documents inviting public input on 

potential changes to our regulations 

relating to records and reports for 

approved new animal drugs, including 

an advance notice of proposed 

rulemaking (77 FR 44177, July 27, 2012) 

and a proposed rule (80 FR 28863, May 

20, 2015). This final rule amends our 

existing records and reports regulation 

in part 514 (21 CFR part 514) to 

incorporate the sales and distribution 

data reporting requirements specific to 

antimicrobial new animal drugs that 

were added to the FD&C Act by ADUFA 

105. ADUFA 105 was enacted to assist 

us in our continuing analysis of the 

interactions (including drug resistance), 

efficacy, and safety of antimicrobials 

approved for use in both humans and 

food-producing animals for the purpose 

of mitigating the public health risk 

associated with antimicrobial resistance. 

This rule includes an additional 

reporting provision intended to improve 

our understanding of antimicrobial 

animal drug sales intended for use in 

specific food-producing animal species. 

This additional provision assists us in 

assessing antimicrobial sales trends in 

the major food-producing animal 

species and examining how such trends 

may relate to antimicrobial resistance. 

Finalizing this rule will assist us in 

assessing the rate at which sponsors are 

voluntarily revising their FDA-approved 

labeled use conditions to promote the 

judicious use of medically important 

antimicrobial drugs in food-producing 

animals. In December 2013, we 

published guidance for industry (GFI) 

#213 (http://www.fda.gov/downloads/

AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/UCM299624.pdf), 

a guidance that calls on sponsors of 

approved medically important 

antimicrobial new animal drugs 

administered through medicated feed or 

water to voluntarily make changes to 

remove production uses (growth 

promotion and feed efficiency) from 

their product labels and bring the 

remaining therapeutic uses of these 

products (to treat, control, or prevent 

disease) under the oversight of a 

veterinarian by the end of December 

2016. All affected drug sponsors 

committed to implementing the changes 

described in guidance for industry (GFI) 

#213 by the December 2016 target date. 

Once the changes are fully 

implemented, it will be illegal to use 

these medically important antibiotics 

for production purposes, and animal 

producers will first need to obtain 

authorization from a licensed 

veterinarian to use them for therapeutic 


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