Establishment of Class E Airspace; Beach, ND, 29128-29129 [2016-10736]
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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
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:
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.
SUMMARY:
FAA Order 7400.9Z,
Airspace Designations and Reporting
Points, and subsequent amendments can
be viewed online at https://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 https://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:
jstallworth on DSK7TPTVN1PROD with RULES
ADDRESSES:
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.
VerDate Sep<11>2014
15:15 May 10, 2016
Jkt 238001
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.
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.
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.
§ 71.1
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
*
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
[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.
E:\FR\FM\11MYR1.SGM
11MYR1
Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations
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
Table of Contents
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.
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 https://
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
jstallworth on DSK7TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:15 May 10, 2016
Jkt 238001
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:
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.
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
29129
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 (https://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
E:\FR\FM\11MYR1.SGM
11MYR1
Agencies
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Rules and Regulations]
[Pages 29128-29129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10736]
[[Page 29128]]
-----------------------------------------------------------------------
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 https://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 https://www.archives.gov/federal_register/code_of_federal-regulations/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
0
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.
Sec. 71.1 [Amended]
0
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[deg]55'31'' N., long. 103[deg]58'55'' W.)
That airspace extending upward from 700 feet above the surface
within a 9-mile radius of Beach Airport.
[[Page 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