Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications; Correction, 53670 [2014-21481]
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53670
Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Proposed Rules
6005 respectively, of FAA Order
7400.9X, dated August 7, 2013, and
effective September 15, 2013, which is
incorporated by reference in 14 CFR
71.1. The Class D and E airspace
designations listed in this document
will be published subsequently in the
Order.
The FAA has determined that this
proposed 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 Regulatory Evaluation
as the anticipated impact is so minimal.
Since this is a routine matter that will
only affect air traffic procedures and air
navigation, it is certified that this
proposed rule, when promulgated,
would not have a significant economic
impact on a substantial number of small
entities under the criteria of the
Regulatory Flexibility Act.
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 proposed 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 proposed regulation is
within the scope of that authority as it
would establish Class D and amend
existing Class E airspace at Paulding
Northwest Atlanta Airport, Dallas, GA.
This proposal will be subject to an
environmental analysis in accordance
with FAA Order 1050.1E,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action. It is anticipated that
this environmental analysis will be
incorporated into the environmental
document described in more detail at 79
FR 22177 (May 21, 2014).
proposes to amend 14 CFR part 71 as
follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
Food and Drug Administration
1. The authority citation for Part 71
will continue to read as follows:
21 CFR Parts 610 and 680
[Docket No. FDA–2014–N–1110]
■
Authority: 49 U.S.C. 106(g); 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
Revocation of General Safety Test
Regulations That Are Duplicative of
Requirements in Biologics License
Applications; Correction
§ 71.1
AGENCY:
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.9X, Airspace
Designations and Reporting Points,
dated August 7, 2013, and effective
September 15, 2013, is amended as
follows:
■
Paragraph 5000
Class D Airspace
*
*
*
ASO GA D
*
*
Dallas, GA [New]
Paulding Northwest Atlanta Airport, GA
(Lat. 33°54′43″ N., long. 84°56′26″ W.)
That airspace extending upward from the
surface up to and including 2,500 feet MSL
within a 4.2-mile radius of Paulding
Northwest Atlanta Airport. This Class D
airspace area is effective during specific dates
and times established in advance by a Notice
to Airmen. The effective date and time will
thereafter be continuously published in the
Airport/Facility Directory.
Paragraph 6005. Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
ASO GA E5
*
ACTION:
Proposed rule; correction.
The Food and Drug
Administration is correcting a proposed
rule entitled ‘‘Revocation of General
Safety Test Regulations That Are
Duplicative of Requirements in
Biological License Applications’’ that
appeared in the Federal Register of
August, 22, 2014. The document
proposed to amend the biologics
regulations by removing the general
safety test requirements for biological
products. The document published with
the incorrect title. This document
corrects that error.
SUMMARY:
Lori
J. Churchyard, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of August 22, 2014, in
FR Doc. 2014–19888, on page 49727, the
following correction is made:
1. On page 49727, in the third
column, in the heading of the
document, ‘‘Revocation of General
Safety Test Regulations That Are
Duplicative of Requirements in
Biological License Applications’’ is
corrected to read ‘‘Revocation of General
Safety Test Regulations That Are
Duplicative of Requirements in
Biologics License Applications’’.
SUPPLEMENTARY INFORMATION:
*
Dallas, GA [Amended]
Paulding Northwest Atlanta Airport, GA
(Lat. 33°54′43″ N., long. 84°56′26″ W.)
That airspace extending upward from 700
feet above the surface within a 6.7-mile
radius of. Paulding Northwest Atlanta
Airport.
Issued in College Park, Georgia, on
September 2, 2014.
Myron A. Jenkins,
Manager, Operations Support Group, Eastern
Service Center, Air Traffic Organization.
[FR Doc. 2014–21582 Filed 9–9–14; 8:45 am]
BILLING CODE 4910–13–P
Food and Drug Administration,
HHS.
Dated: September 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21481 Filed 9–9–14; 8:45 am]
Lists of Subjects in 14 CFR Part 71:
Airspace, Incorporation by reference,
Navigation (Air).
BILLING CODE 4164–01–P
The Proposed Amendment
In consideration of the foregoing, the
Federal Aviation Administration
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Agencies
[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Proposed Rules]
[Page 53670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21481]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 610 and 680
[Docket No. FDA-2014-N-1110]
Revocation of General Safety Test Regulations That Are
Duplicative of Requirements in Biologics License Applications;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a proposed rule
entitled ``Revocation of General Safety Test Regulations That Are
Duplicative of Requirements in Biological License Applications'' that
appeared in the Federal Register of August, 22, 2014. The document
proposed to amend the biologics regulations by removing the general
safety test requirements for biological products. The document
published with the incorrect title. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 22, 2014,
in FR Doc. 2014-19888, on page 49727, the following correction is made:
1. On page 49727, in the third column, in the heading of the
document, ``Revocation of General Safety Test Regulations That Are
Duplicative of Requirements in Biological License Applications'' is
corrected to read ``Revocation of General Safety Test Regulations That
Are Duplicative of Requirements in Biologics License Applications''.
Dated: September 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21481 Filed 9-9-14; 8:45 am]
BILLING CODE 4164-01-P