Amendment to Class E Airspace; Smithfield, NC, 59934-59935 [2010-24113]
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59934
Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations
construction contained in RUS Bulletin
1753F–150 (RUS Form 515a).
The current outside plant
specifications are used by borrowers to
secure the services of a contractor for
the construction of telecommunications
facilities. Current specifications have
become outdated due to the
advancements in Fiber-to-the-Home
construction as well as installation
methods and materials. In order for
borrowers and contractors to take
advantage of these improved
construction installation methods and
materials, the current specifications
have been revised.
On Tuesday, June 8, 2010, RUS
published a proposed rule in the
Federal Register (Vol. 75, No 109, page
32313), proposing to amend its
regulations on Telecommunications
Policies on Specifications, Acceptable
Materials, and Standard Contract Forms,
by revising RUS Bulletin 1753F–150,
Specifications and Drawings for
Construction of Direct Buried Plant
(Form 515a). Interested parties were
invited to submit comments on or before
August 9, 2010. No comments were
received.
List of Subjects in 7 CFR Part 1755
Incorporation by reference, Loan
programs—communications, Reporting
and recordkeeping requirements, Rural
areas, Telephone.
For reasons set out in the preamble,
RUS proposes to amend chapter XVII of
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title 7 of the Code of Federal
Regulations as follows:
PART 1755—TELECOMMUNICATIONS
POLICIES ON SPECIFICATIONS,
ACCEPTABLE MATERIALS, AND
STANDARD CONTRACT FORMS
1. The authority citation for part 1755
continues to read as follow:
■
Authority: 7 U.S.C. 901 et seq., 1921 et
seq., 6941 et seq.
2. In § 1755.97, the table is amended
by revising the issue date of RUS
Bulletin 1753F–150 to read as follows:
■
§ 1755.97 Incorporation by reference of
telecommunications standards and
specifications.
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RUS Bulletin No.
Specification No.
Date last issued
Title of standard or specification
*
1753F–150 .........................
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Form 515a .........................
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September 2010 ................
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Specifications and Drawings for Construction of Direct
Buried Plant.
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Dated: September 23, 2010.
Jonathan Adelstein,
Administrator, Rural Utilities Service.
[FR Doc. 2010–24420 Filed 9–28–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
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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.
FOR FURTHER INFORMATION CONTACT:
Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal
Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320;
telephone (404) 305–5610.
SUPPLEMENTARY INFORMATION:
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule, technical
amendment.
History
The FAA received a request from the
National Aeronautical Navigation
Services to correct the omission of the
geographic coordinates for the point in
space serving Johnston Memorial
Hospital in the amendment of the Class
E airspace published in the Federal
Register on July 27, 2010 (75 FR 43817).
This action makes the adjustment.
This action amends Class E
airspace at Johnston County Airport,
Smithfield, NC, by correcting an
omission of the geographic coordinates
of the Area Navigation (RNAV) Global
Positioning System (GPS) Special
Standard Instrument Approach
Procedure (SIAP) serving the Johnston
Memorial Hospital to aid in the
navigation of our National Airspace
System.
DATES: Effective 0901 UTC, January 13,
2011. The Director of the Federal
Register approves this incorporation by
The Rule
This amendment to Title 14, Code of
Federal Regulations (14 CFR) part 71
amends Class E airspace at Smithfield,
NC, by making the addition of the
geographic coordinates of the RNAV
(GPS) approach point in space serving
Johnston Memorial Hospital to coincide
with the FAAs National Aeronautical
Navigation Services depiction.
Accordingly, since this is an
administrative change, and does not
involve a change in the dimensions or
operating requirements of that airspace,
[Docket No. FAA–2010–0911; Airspace
Docket No. 10–ASO–32]
Amendment to Class E Airspace;
Smithfield, NC
AGENCY:
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SUMMARY:
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notice and public procedures under 5
U.S.C. 553 (b) are unnecessary.
The Class E airspace designations are
published in Paragraph 6005 of FAA
order 7400.9U, dated August 18, 2010,
and effective September 15, 2010, 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.
The FAA has determined that his
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 will only affect air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, will 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.
E:\FR\FM\29SER1.SGM
29SER1
Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations
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 controlled airspace at
Smithfield, NC.
Issued in College Park, Georgia, on
September 17, 2010.
Myron A. Jenkins,
Acting Manager, Operations Support Group,
Eastern Service Center, Air Traffic
Organization.
Lists of Subjects in 14 CFR Part 71
21 CFR Parts 312 and 320
Airspace, Incorporation by reference,
Navigation (Air).
Adoption of the Amendment
[FR Doc. 2010–24113 Filed 9–28–10; 8:45 am]
BILLING CODE 4910–13–P
Food and Drug Administration
[Docket No. FDA–2000–N–0108] (formerly
Docket No. 00N–1484)
RIN 0910–AG13
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and
Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans
AGENCY:
1. The authority citation for Part 71
continues to read as follows:
■
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U,
Airspace Designations and Reporting
Points, dated August 18, 2010, and
effective September 15, 2010, is
amended as follows:
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Paragraph 6005 Class E Airspace Extending
Upward From 700 feet or More Above the
Surface of the Earth
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erowe on DSK5CLS3C1PROD with RULES
ASO NC E5
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Smithfield, NC [Amended]
Johnston County Airport, NC
(Lat. 35°32′27″ N., long 78°23′25″ W.)
Johnston Memorial Hospital
Point In Space Coordinates
(Lat. 35°31′23″ N., long 78°20′35″ W.)
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of the Johnston County Airport and
within 2 miles each side of the 023° bearing
from the airport extending from the 6.5-mile
radius to 10.2 miles northeast of the Johnston
County Airport and within a 6-mile radius of
the point in space (lat.35°31′23″ N., long.
78°20′35″ W.) serving Johnston Memorial
Hospital.
VerDate Mar<15>2010
14:30 Sep 28, 2010
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Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending its
regulations governing safety reporting
requirements for human drug and
biological products subject to an
investigational new drug application
(IND). The final rule codifies the
agency’s expectations for timely review,
evaluation, and submission of relevant
and useful safety information and
implements internationally harmonized
definitions and reporting standards. The
revisions will improve the utility of IND
safety reports, reduce the number of
reports that do not contribute in a
meaningful way to the developing safety
profile of the drug, expedite FDA’s
review of critical safety information,
better protect human subjects enrolled
in clinical trials, subject bioavailability
and bioequivalence studies to safety
reporting requirements, promote a
consistent approach to safety reporting
internationally, and enable the agency
to better protect and promote public
health.
DATES: This rule is effective March 28,
2011.
FOR FURTHER INFORMATION CONTACT:
For information on IND safety
reporting for human drug products:
Janet Norden, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6324,
Silver Spring, MD 20993–0002, 301–
796–2500.
SUMMARY:
Authority: 49 U.S.C. 106(g); 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
For information on IND safety
reporting for human biological products:
Laura Rich, Center for Biologics
Evaluation and Research, Food and
Drug Administration,1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
Table of Contents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR Part 71 as follows:
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I. Background
A. Rationale for Rulemaking
B. The Proposed Rule
II. Overview of the Final Rule
A. Definitions
B. Review of Safety Information
C. Reporting Requirements
III. Comments on the Proposed Rule
A. Definitions—Proposed § 312.32(a)
B. Review of Safety Information—
Proposed § 312.32(b)
C. IND Safety Reports (Requirement
for Minimum Data Set)—Proposed
§ 312.32(c)
D. Serious and Unexpected SADR—
Proposed § 312.32(c)(1)(i)
E. Alternative Reporting
Arrangements
F. Unblinding
G. Information Sufficient to Consider
Product Administration Changes—
Proposed § 312.32(c)(1)(ii)
H. Submission of Written Reports—
Proposed § 312.32(c)(1)(iii)
I. Telephone and Facsimile
Transmission Safety Reports—
Proposed § 312.32(c)(2)
J. Investigations of Marketed Drugs—
Proposed § 312.32(c)(4)
K. Followup—Proposed § 312.32(d)
L. Disclaimer—Proposed § 312.32(e)
M. Annual Reports
N. Investigator Reports—Proposed
§ 312.64(b)
O. Bioavailability and Bioequivalence
Requirements—Proposed
§ 320.31(d)
P. Reports to Investigators and IRBs
Q. Miscellaneous Comments
R. Initial Analysis of Impacts and
Paperwork Burden Estimates
IV. Legal Authority
V. Environmental Impact
VI. Analysis of Impacts
A. Need for the Regulation
B. Costs of the Regulation (to Prepare
and Submit Safety Reports)
C. Benefits of the Regulation
D. Final Regulatory Flexibility
Analysis
VII. Paperwork Reduction Act of 1995
VIII. Executive Order 13132: Federalism
IX. References
I. Background
In the Federal Register of March 14,
2003 (68 FR 12406), FDA issued a
proposed rule to revise its regulations
governing pre- and postmarketing safety
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Agencies
[Federal Register Volume 75, Number 188 (Wednesday, September 29, 2010)]
[Rules and Regulations]
[Pages 59934-59935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24113]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2010-0911; Airspace Docket No. 10-ASO-32]
Amendment to Class E Airspace; Smithfield, NC
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule, technical amendment.
-----------------------------------------------------------------------
SUMMARY: This action amends Class E airspace at Johnston County
Airport, Smithfield, NC, by correcting an omission of the geographic
coordinates of the Area Navigation (RNAV) Global Positioning System
(GPS) Special Standard Instrument Approach Procedure (SIAP) serving the
Johnston Memorial Hospital to aid in the navigation of our National
Airspace System.
DATES: Effective 0901 UTC, January 13, 2011. 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.
FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone (404) 305-5610.
SUPPLEMENTARY INFORMATION:
History
The FAA received a request from the National Aeronautical
Navigation Services to correct the omission of the geographic
coordinates for the point in space serving Johnston Memorial Hospital
in the amendment of the Class E airspace published in the Federal
Register on July 27, 2010 (75 FR 43817). This action makes the
adjustment.
The Rule
This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace at Smithfield, NC, by making the
addition of the geographic coordinates of the RNAV (GPS) approach point
in space serving Johnston Memorial Hospital to coincide with the FAAs
National Aeronautical Navigation Services depiction. Accordingly, since
this is an administrative change, and does not involve a change in the
dimensions or operating requirements of that airspace, notice and
public procedures under 5 U.S.C. 553 (b) are unnecessary.
The Class E airspace designations are published in Paragraph 6005
of FAA order 7400.9U, dated August 18, 2010, and effective September
15, 2010, 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.
The FAA has determined that his 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 will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will 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.
[[Page 59935]]
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 controlled airspace at Smithfield, NC.
Lists of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (Air).
Adoption of the Amendment
0
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(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 Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, and effective September 15, 2010, is
amended as follows:
Paragraph 6005 Class E Airspace Extending Upward From 700 feet or
More Above the Surface of the Earth
* * * * *
ASO NC E5 Smithfield, NC [Amended]
Johnston County Airport, NC
(Lat. 35[deg]32[min]27[sec] N., long 78[deg]23[min]25[sec] W.)
Johnston Memorial Hospital
Point In Space Coordinates
(Lat. 35[deg]31[min]23[sec] N., long 78[deg]20[min]35[sec] W.)
That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the Johnston County Airport and within 2
miles each side of the 023[deg] bearing from the airport extending
from the 6.5-mile radius to 10.2 miles northeast of the Johnston
County Airport and within a 6-mile radius of the point in space
(lat.35[deg]31[min]23[sec] N., long. 78[deg]20[min]35[sec] W.)
serving Johnston Memorial Hospital.
Issued in College Park, Georgia, on September 17, 2010.
Myron A. Jenkins,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2010-24113 Filed 9-28-10; 8:45 am]
BILLING CODE 4910-13-P