Amendment of Class E Airspace; Pittsfield, MA, 68330-68331 [2019-26857]
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68330
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
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(IBR) of the service information listed in this
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this AD, unless the AD specifies otherwise.
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(4) You may view this service information
at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For
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(5) You may view this service information
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Administration (NARA). For information on
the availability of this material at NARA,
email fedreg.legal@nara.gov, or go to: https://
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Issued in Des Moines, Washington, on
November 20, 2019.
Dorr Anderson,
Acting Director, System Oversight Division,
Aircraft Certification Service.
Authority for This Rulemaking
[FR Doc. 2019–26963 Filed 12–13–19; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2019–0563; Airspace
Docket No. 19–ANE–4]
RIN 2120–AA66
Amendment of Class E Airspace;
Pittsfield, MA
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:
This action amends Class E
airspace extending upward from 700
feet above the surface at Pittsfield
Municipal Airport, Pittsfield, MA, to
accommodate airspace reconfiguration
due to the redesign of the Localizer
(LOC)/Distance Measuring Equipment
(DME) Runway (RWY) 26 approach.
Controlled airspace is necessary for the
safety and management of instrument
flight rules (IFR) operations at this
airport. This action also updates the
geographic coordinates of this airport.
lotter on DSKBCFDHB2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
Effective 0901 UTC, January 30,
2020. 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
7400.11 and publication of conforming
amendments.
ADDRESSES: FAA Order 7400.11D,
Airspace Designations and Reporting
Points, and subsequent amendments can
be viewed on line 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 7400.11D at NARA, email
fedreg.legal@nara.gov or go to https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
FOR FURTHER INFORMATION CONTACT: John
Fornito, Operations Support Group,
Eastern Service Center, Federal Aviation
Administration, 1701 Columbia Ave,
College Park, GA 30337; telephone (404)
305–6364.
SUPPLEMENTARY INFORMATION:
DATES:
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 extending upward from
700 feet above the surface for Pittsfield
Municipal Airport, Pittsfield, MA, due
to the redesign of the LOC/DME RWY
26 approach.
History
The FAA published a notice of
proposed rulemaking in the Federal
Register (84 FR 41938, August 16, 2019)
for Docket No. FAA–2019–0563 to
amend Class E airspace extending
upward from 700 feet above the surface
for Pittsfield Municipal Airport,
Pittsfield, MA, due to the redesign of the
LOC/DME RWY 26 approach.
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
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 7400.11D, dated August 8, 2019,
and effective September 15, 2019, 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
7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019,
and effective September 15, 2019. FAA
Order 7400.11D is publicly available as
listed in the ADDRESSES section of this
document. FAA Order 7400.11D 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
amends Class E airspace extending
upward from 700 feet above the surface
at Pittsfield Municipal Airport,
Pittsfield, MA, by increasing the airport
radius to 9.6 miles (from 4 miles),
enlarging the northeast extension of the
airport to 6-miles each side of a 064°
bearing of the airport, extending from
the 9.6-mile radius to 18-miles northeast
of the airport, and eliminating the
southwest extension of the airport to
accommodate airspace reconfiguration
due to the redesign of the LOC/DME
RWY 26 approach into the airport. Also,
the geographic coordinates of the airport
are adjusted to coincide with the FAA’s
aeronautical database. These changes
are necessary for continued safety and
management of IFR operations at this
airport.
FAA Order 7400.11, Airspace
Designations and Reporting Points, is
published yearly and effective on
September 15.
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 DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
E:\FR\FM\16DER1.SGM
16DER1
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
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.
Issued in College Park, Georgia, on
December 4, 2019.
Ryan Almasy,
Manager, Operations Support Group, Eastern
Service Center, Air Traffic Organization.
Environmental Review
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 exist
that warrant preparation of an
environmental assessment.
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.
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting
Points, dated August 8, 2019, effective
September 15, 2019, is amended as
follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
lotter on DSKBCFDHB2PROD with RULES
ANE MA E5
*
*
Pittsfield, MA [Amended]
Pittsfield Municipal Airport, MA
(Lat. 42°25′39″ N, long. 73°17′27″ W)
That airspace extending upward from 700
feet above the surface within a 9.6-mile
radius of the Pittsfield Municipal Airport,
and within 6-miles each side of the 064°
bearing of the airport, extending from the 9.6mile radius to 18-miles northeast of the
airport.
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
Table of Contents
I. Executive Summary
II. Background
III. Legal Authority
IV. Comments on the Proposed Rule
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With
Indian Tribal Governments
XI. Reference
Food and Drug Administration
I. Executive Summary
21 CFR Part 310
In this final rule, FDA repeals the
irradiation regulation, which provided
that any drug sterilized by irradiation
was a new drug. OTC drugs marketed
pursuant to the OTC Drug Review that
are generally recognized as safe and
effective, are not misbranded, and
comply with all applicable regulatory
requirements now can be marketed
legally without an FDA-approved NDA
or ANDA, even if the drugs are
sterilized by irradiation. As the Agency
explained in the proposed rule
published in the Federal Register of
September 12, 2018 (83 FR 46121), FDA
is taking this action because the Agency
no longer concludes that drugs
sterilized by irradiation are necessarily
new drugs. The technology of controlled
nuclear radiation for sterilization of
drugs is now well understood. In
addition, drugs that are marketed
pursuant to the OTC Drug Review must
be manufactured in compliance with
current good manufacturing practices
(CGMPs). Appropriate and effective
sterilization of drugs, including by
irradiation, is adequately addressed by
the CGMP requirements. Repealing the
irradiation regulation eliminates a
requirement that is no longer necessary
and will not diminish public health
protections.
The estimated one-time costs of this
rule range from $25 to $32. Avoiding the
unnecessary preparation and review of
a premarket drug application will
generate an estimated one-time cost
savings that range from about $0.40
million to $2.16 million. Over 10 years
with a 7 percent discount rate, the
annualized net cost savings range from
$0.05 million to $0.29 million, with a
primary estimate of $0.06 million; with
a 3 percent discount rate, the
annualized net cost savings range from
$0.05 million to $0.25 million, with a
primary estimate of $0.05 million. Over
an infinite horizon, we assume that one
sponsor will benefit from this
deregulatory action every 10 years; the
present value of the net cost savings
over the infinite horizon range from
$0.76 million to $4.11 million with a 7
[Docket No. FDA–2017–N–6924]
RIN 0910–AH47
Regulation Requiring an Approved
New Drug Application for Drugs
Sterilized by Irradiation
Food and Drug Administration,
HHS.
Airspace, Incorporation by reference,
Navigation (air).
*
BILLING CODE 4910–13–P
AGENCY:
Lists of Subjects in 14 CFR Part 71
§ 71.1
[FR Doc. 2019–26857 Filed 12–13–19; 8:45 am]
68331
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing a final rule repealing a
regulation that requires an FDAapproved new drug application (NDA)
or abbreviated new drug application
(ANDA) for any drug product that is
sterilized by irradiation (the irradiation
regulation). Repealing the irradiation
regulation will mean that over-thecounter (OTC) drug products that are
generally recognized as safe and
effective, are not misbranded, and
comply with all applicable regulatory
requirements can be marketed legally
without an NDA or ANDA, even if they
are sterilized by irradiation. FDA is
taking this action because the
irradiation regulation is out of date and
unnecessary.
DATES: This rule is effective January 15,
2020.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sudha Shukla, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5234,
Silver Spring, MD 20993–0002, 301–
796–3345.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
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Fmt 4700
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E:\FR\FM\16DER1.SGM
16DER1
Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Rules and Regulations]
[Pages 68330-68331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26857]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2019-0563; Airspace Docket No. 19-ANE-4]
RIN 2120-AA66
Amendment of Class E Airspace; Pittsfield, MA
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action amends Class E airspace extending upward from 700
feet above the surface at Pittsfield Municipal Airport, Pittsfield, MA,
to accommodate airspace reconfiguration due to the redesign of the
Localizer (LOC)/Distance Measuring Equipment (DME) Runway (RWY) 26
approach. Controlled airspace is necessary for the safety and
management of instrument flight rules (IFR) operations at this airport.
This action also updates the geographic coordinates of this airport.
DATES: Effective 0901 UTC, January 30, 2020. 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 7400.11 and publication of conforming amendments.
ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line 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 7400.11D at NARA, email [email protected]
or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave, College Park, GA 30337; telephone (404) 305-6364.
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 extending upward from 700 feet above the
surface for Pittsfield Municipal Airport, Pittsfield, MA, due to the
redesign of the LOC/DME RWY 26 approach.
History
The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 41938, August 16, 2019) for Docket No. FAA-2019-0563 to
amend Class E airspace extending upward from 700 feet above the surface
for Pittsfield Municipal Airport, Pittsfield, MA, due to the redesign
of the LOC/DME RWY 26 approach.
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 7400.11D, dated August 8, 2019, and effective September 15,
2019, 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 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D 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 amends Class E airspace extending upward from 700 feet above
the surface at Pittsfield Municipal Airport, Pittsfield, MA, by
increasing the airport radius to 9.6 miles (from 4 miles), enlarging
the northeast extension of the airport to 6-miles each side of a
064[deg] bearing of the airport, extending from the 9.6-mile radius to
18-miles northeast of the airport, and eliminating the southwest
extension of the airport to accommodate airspace reconfiguration due to
the redesign of the LOC/DME RWY 26 approach into the airport. Also, the
geographic coordinates of the airport are adjusted to coincide with the
FAA's aeronautical database. These changes are necessary for continued
safety and management of IFR operations at this airport.
FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.
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 DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a
[[Page 68331]]
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 exist 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
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 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019,
effective September 15, 2019, is amended as follows:
Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.
* * * * *
ANE MA E5 Pittsfield, MA [Amended]
Pittsfield Municipal Airport, MA
(Lat. 42[deg]25'39'' N, long. 73[deg]17'27'' W)
That airspace extending upward from 700 feet above the surface
within a 9.6-mile radius of the Pittsfield Municipal Airport, and
within 6-miles each side of the 064[deg] bearing of the airport,
extending from the 9.6-mile radius to 18-miles northeast of the
airport.
Issued in College Park, Georgia, on December 4, 2019.
Ryan Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2019-26857 Filed 12-13-19; 8:45 am]
BILLING CODE 4910-13-P