New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Confirmation of Effective Date, 37175 [2014-15209]
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Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Rules and Regulations
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.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the U.S. Code. Subtitle 1,
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 Memphis
Memorial Airport, Memphis, MO.
§ 71.1
Environmental Review
21 CFR Part 514
DEPARTMENT OF THE TREASURY
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1E, ‘‘Environmental
Impacts: Policies and Procedures,’’
paragraph 311a. 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.
[Docket No. FDA–2014–N–0108]
Internal Revenue Service
New Animal Drug Applications;
Confidentiality of Data and Information
in a New Animal Drug Application File;
Confirmation of Effective Date
26 CFR Part 1
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (Air)
Adoption of the Amendment
pmangrum on DSK3VPTVN1PROD with RULES
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 14 CFR
Part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
VerDate Mar<15>2010
15:01 Jun 30, 2014
Jkt 232001
[Amended]
37175
2. The incorporation by reference in
14 CFR Part 71.1 of the 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 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface.
*
*
*
*
*
ACE MO E5 Memphis, MO [New]
Memphis Memorial Airport, MO
(Lat. 40°26′50″ N., long. 92°13′37″ W.)
That airspace extending upward from 700
feet above the surface within a 6.3-mile
radius of Memphis Memorial Airport.
Issued in Fort Worth, Texas, on June 18,
2014.
Kent M. Wheeler,
Manager, Operations Support Group, ATO
Central Service Center.
[FR Doc. 2014–15180 Filed 6–30–14; 8:45 am]
BILLING CODE 4910–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of July 30, 2014, for the
final rule that appeared in the Federal
Register of March 17, 2014. The direct
final rule amends the regulation
regarding the confidentiality of data and
information in and about new animal
drug application files to change when
certain approval-related information
will be disclosed by the Agency. This
change ensures that the Agency is able
to update its list of approved new
animal drug products within the
statutory timeframe. It also permits
more timely public disclosure of
approval-related information, increasing
the transparency of FDA
decisionmaking in the approval of new
animal drugs. This document confirms
the effective date of the direct final rule.
SUMMARY:
PO 00000
Frm 00021
Fmt 4700
Effective date of final rule
published in the Federal Register of
March 17, 2014 (79 FR 14609)
confirmed: July 30, 2014.
FOR FURTHER INFORMATION CONTACT:
Scott Fontana, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0656.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 17, 2014 (79
FR 14609), FDA solicited comments
concerning the direct final rule for a 75day period ending June 2, 2014. FDA
stated that the effective date of the
direct final rule would be on July 30,
2014, 30 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
DATES:
Sfmt 4700
Authority: 21 U.S.C. 321, 331, 351, 352,
356a, 360b, 371, 379e, 381.
Accordingly, the amendments issued
thereby are effective.
Dated: June 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15209 Filed 6–30–14; 8:45 am]
BILLING CODE 4164–01–P
[TD 9657]
RIN 1545–BL73
Regulations Relating to Information
Reporting by Foreign Financial
Institutions and Withholding on
Certain Payments to Foreign Financial
Institutions and Other Foreign Entities;
Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendments.
AGENCY:
This document contains
corrections to final and temporary
regulations (TD 9657), which were
published in the Federal Register on
Thursday, March 6, 2014 (79 FR 12812).
The regulations relate to information
reporting by foreign financial
institutions (FFIs) with respect to U.S.
accounts and withholding on certain
payments to FFIs and other foreign
entities.
DATES: Effective Date: These corrections
are effective on July 1, 2014.
Applicability Date: These corrections
are applicable on March 6, 2014.
SUMMARY:
E:\FR\FM\01JYR1.SGM
01JYR1
]]>Agencies
[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Rules and Regulations]
[Page 37175]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15209]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 514
[Docket No. FDA-2014-N-0108]
New Animal Drug Applications; Confidentiality of Data and
Information in a New Animal Drug Application File; Confirmation of
Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of July 30, 2014, for the final rule that appeared in
the Federal Register of March 17, 2014. The direct final rule amends
the regulation regarding the confidentiality of data and information in
and about new animal drug application files to change when certain
approval-related information will be disclosed by the Agency. This
change ensures that the Agency is able to update its list of approved
new animal drug products within the statutory timeframe. It also
permits more timely public disclosure of approval-related information,
increasing the transparency of FDA decisionmaking in the approval of
new animal drugs. This document confirms the effective date of the
direct final rule.
DATES: Effective date of final rule published in the Federal Register
of March 17, 2014 (79 FR 14609) confirmed: July 30, 2014.
FOR FURTHER INFORMATION CONTACT: Scott Fontana, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0656.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 17, 2014
(79 FR 14609), FDA solicited comments concerning the direct final rule
for a 75-day period ending June 2, 2014. FDA stated that the effective
date of the direct final rule would be on July 30, 2014, 30 days after
the end of the comment period, unless any significant adverse comment
was submitted to FDA during the comment period. FDA did not receive any
significant adverse comments.
Authority: 21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e,
381.
Accordingly, the amendments issued thereby are effective.
Dated: June 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15209 Filed 6-30-14; 8:45 am]
BILLING CODE 4164-01-P
