Revision of VOR Federal Airway V-537, 39917-39918 [05-13682]
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Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA 2003–16676; Airspace
Docket No. 03–ASO–16]
RIN 2120–AA66
Revision of VOR Federal Airway V–537
I
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
AGENCY:
PART 71—DESIGNATION OF CLASS A,
CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; ROUTES;
AND REPORTING POINTS.
SUMMARY: This action revises Very High
Frequency Omnidirectional Range
(VOR) Federal Airway V–537 by
changing the origination point of the
airway from the Vero Beach, FL, Very
High Frequency Omnidirectional Range/
Tactical Air Navigation (VORTAC) to
the Palm Beach, FL, VORTAC. The FAA
is taking this action to enhance the
management of aircraft in the Palm
Beach, FL, area.
EFFECTIVE DATE: 0901 UTC, October 27,
2005.
FOR FURTHER INFORMATION CONTACT: Paul
Gallant, Airspace and Rules, Office of
System Operations and Safety, Federal
Aviation Administration, 800
Independence Avenue, SW.,
Washington, DC 20591; telephone: (202)
267–8783.
SUPPLEMENTARY INFORMATION:
1. The authority citation for 14 CFR
part 71 continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in 14
CFR part 71.1 of the Federal Aviation
Administration Order 7400.9M,
Airspace Designations and Reporting
Points, dated August 30, 2004, and
effective September 16, 2004, is
amended as follows:
I
Paragraph 6002 Class E Airspace area
extending upward from the surface of the
earth.
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
Background
Aspen-Pitkin County/Sardy Field
(Lat. 39°13′23″ N., long. 106°52′08″ W.)
Within a 4.3-mile radius of Aspen-Pitkin
County/Sardy Field. This Class E airspace 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.
On February 3, 2004, the FAA
proposed to modify V–537 by changing
the origination point of the airway from
the Vero Beach VORTAC to the Palm
Beach VORTAC (69 FR 5098). Interested
parties were invited to participate in
this rulemaking effort by submitting
written comments on the proposal. No
comments were received. With the
exception of editorial changes, this
amendment is the same as that proposed
in the notice.
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The Rule
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ANM OR E2
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Aspen, CO [Added]
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Issued in Seattle, Washington on June 10,
2005.
˜
Raul C. Trevino,
Area Director, Western En Route and Oceanic
Operations.
[FR Doc. 05–13644 Filed 7–11–05; 8:45 am]
BILLING CODE 4910–13–M
VerDate jul<14>2003
14:34 Jul 11, 2005
Jkt 205001
This action amends Title 14 Code of
Federal Regulations (14 CFR) part 71 by
revising the legal description of V–537
in the vicinity of Palm Beach, FL. The
revision incorporates into the airway
routing that is used by air traffic control
when directing aircraft to Palm Beach,
FL. Currently, Miami Air Route Traffic
Control Center issues a clearance to
aircraft destined for the Palm Beach
terminal area by directing aircraft to
proceed via the Vero Beach VORTAC,
then along V–295 to STOOP
intersection, then via V–492 to the Palm
Beach VORTAC. This modification
incorporates this routing as an extension
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
39917
to V–537. The modification to V–537
will reduce pilot-controller
communications, alleviate radio
frequency congestion, reduce the
potential for pilot readback errors, and
enhance the management of aircraft
operations in the Vero Beach-Palm
Beach area.
Domestic VOR Federal airways are
published in paragraph 6010(a) of FAA
Order 7400.9M, dated August 30, 2004,
and effective September 16, 2004, which
is incorporated by reference in 14 CFR
71.1. The VOR Federal airway listed in
this document will be published
subsequently in the order.
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. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under Department of
Transportation (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.
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:
I
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:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9M,
Airspace Designations and Reporting
Points, dated August 30, 2004, and
effective September 16, 2004, is
amended as follows:
Paragraph 6010(a)—Domestic VOR Federal
Airways.
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E:\FR\FM\12JYR1.SGM
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12JYR1
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39918
Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations
V–537 [Revised]
From Palm Beach, FL; INT Palm Beach
356° and Vero Beach, FL, 143° radials; Vero
Beach; INT Vero Beach 318° and Orlando.
FL, 140° radials; INT Orlando 140° and
Melbourne, FL 298° radials; INT Melbourne
298° and Ocala, FL 145° radials; Ocala;
Gators, FL; Greenville, FL; Moultrie, GA; to
Macon, GA.
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Issued in Washington, DC, on July 6, 2005.
Edith V. Parish,
Acting Manager, Airspace and Rules.
[FR Doc. 05–13682 Filed 7–11–05; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
Implantation or Injectable Dosage
Form New Animal Drugs;
Tulathromycin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Pfizer, Inc.
The NADA provides for the veterinary
prescription use of tulathromycin
solution in cattle and in swine, by
injection, for the management of
respiratory disease. FDA is also
amending the regulations to add the
acceptable daily intake for total residues
of tulathromycin and tolerances for
residues of tulathromycin in edible
tissues of cattle and swine.
DATES: This rule is effective July 12,
2005.
FOR FURTHER INFORMATION CONTACT:
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Pfizer,
Inc., 235 East 42d St., New York, NY
10017, filed NADA 141–244 for
DRAXXIN (tulathromycin) Injectable
Solution. The NADA provides for the
veterinary prescription use of
tulathromycin solution in cattle, by
subcutaneous injection, for the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni (Haemophilus
somnus); for the control of respiratory
VerDate jul<14>2003
14:34 Jul 11, 2005
Jkt 205001
disease in cattle at high risk of
developing BRD associated with M.
haemolytica, P. multocida, and H.
somni; and in swine, by intramuscular
injection, for the treatment of swine
respiratory disease (SRD) associated
with Actinobacillus pleuropneumoniae,
P. multocida, Bordetella bronchiseptica,
and H. parasuis. The application is
approved as of May 24, 2005, and the
regulations are amended in part 522 (21
CFR part 522) by adding § 522.2630 and
in part 556 (21 CFR part 556) by adding
§ 556.745 to reflect the approval. The
basis of approval is discussed in the
freedom of information (FOI) summary.
In accordance with the FOI provisions
of 21 CFR part 20 and 21 CFR
514.11(e)(2)(ii), a summary of safety and
effectiveness data and information
submitted to support approval of this
application may be seen in the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
marketing exclusivity beginning May
24, 2005.
The agency has determined under 21
CFR 25.33(d)(5) that these actions are of
a type that do not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to the
Center for Veterinary Medicine, 21 CFR
parts 522 and 556 are amended as
follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
PO 00000
Authority: 21 U.S.C. 360b.
Frm 00014
Fmt 4700
Sfmt 4700
2. Section 522.2630 is added to read as
follows:
I
§ 522.2630
Tulathromycin.
(a) Specifications. Each milliliter of
solution contains 100 milligrams (mg)
tulathromycin.
(b) Sponsor. See No. 000069 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.745
of this chapter.
(d) Conditions of use—(1) Beef and
nonlactating dairy cattle—(i) Amount.
2.5 mg per kilogram (/kg) body weight
as a single subcutaneous injection in the
neck.
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni (Haemophilus
somnus); for the control of respiratory
disease in cattle at high risk of
developing BRD associated with M.
haemolytica, P. multocida, and H.
somni.
(iii) Limitations. Cattle intended for
human consumption must not be
slaughtered within 18 days from the last
treatment. Do not use in female dairy
cattle 20 months of age or older. A
withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Swine—(i) Amount. 2.5 mg/kg
body weight as a single intramuscular
injection in the neck.
(ii) Indications for use. For the
treatment of swine respiratory disease
(SRD) associated with Actinobaccillus
pleuropneumoniae, P. multocida,
Bordetella bronchiseptica, and H.
parasuis.
(iii) Limitations. Swine intended for
human consumption must not be
slaughtered within 5 days from the last
treatment. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
3. The authority citation for 21 CFR
part 556 continues to read as follows:
I
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.745 is added to read as
follows:
I
§ 556.745
Tulathromycin.
(a) Acceptable daily intake (ADI). The
ADI for total residues of tulathromycin
is 15 micrograms per kilogram of body
weight per day.
E:\FR\FM\12JYR1.SGM
12JYR1
Agencies
[Federal Register Volume 70, Number 132 (Tuesday, July 12, 2005)]
[Rules and Regulations]
[Pages 39917-39918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13682]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA 2003-16676; Airspace Docket No. 03-ASO-16]
RIN 2120-AA66
Revision of VOR Federal Airway V-537
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
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SUMMARY: This action revises Very High Frequency Omnidirectional Range
(VOR) Federal Airway V-537 by changing the origination point of the
airway from the Vero Beach, FL, Very High Frequency Omnidirectional
Range/Tactical Air Navigation (VORTAC) to the Palm Beach, FL, VORTAC.
The FAA is taking this action to enhance the management of aircraft in
the Palm Beach, FL, area.
EFFECTIVE DATE: 0901 UTC, October 27, 2005.
FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace and Rules,
Office of System Operations and Safety, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone: (202) 267-8783.
SUPPLEMENTARY INFORMATION:
Background
On February 3, 2004, the FAA proposed to modify V-537 by changing
the origination point of the airway from the Vero Beach VORTAC to the
Palm Beach VORTAC (69 FR 5098). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. No comments were received. With the exception of
editorial changes, this amendment is the same as that proposed in the
notice.
The Rule
This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by revising the legal description of V-537 in the vicinity of
Palm Beach, FL. The revision incorporates into the airway routing that
is used by air traffic control when directing aircraft to Palm Beach,
FL. Currently, Miami Air Route Traffic Control Center issues a
clearance to aircraft destined for the Palm Beach terminal area by
directing aircraft to proceed via the Vero Beach VORTAC, then along V-
295 to STOOP intersection, then via V-492 to the Palm Beach VORTAC.
This modification incorporates this routing as an extension to V-537.
The modification to V-537 will reduce pilot-controller communications,
alleviate radio frequency congestion, reduce the potential for pilot
readback errors, and enhance the management of aircraft operations in
the Vero Beach-Palm Beach area.
Domestic VOR Federal airways are published in paragraph 6010(a) of
FAA Order 7400.9M, dated August 30, 2004, and effective September 16,
2004, which is incorporated by reference in 14 CFR 71.1. The VOR
Federal airway listed in this document will be published subsequently
in the order.
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.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (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.
List 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]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9M, Airspace Designations and Reporting Points, dated August 30,
2004, and effective September 16, 2004, is amended as follows:
Paragraph 6010(a)--Domestic VOR Federal Airways.
* * * * *
[[Page 39918]]
V-537 [Revised]
From Palm Beach, FL; INT Palm Beach 356[deg] and Vero Beach, FL,
143[deg] radials; Vero Beach; INT Vero Beach 318[deg] and Orlando.
FL, 140[deg] radials; INT Orlando 140[deg] and Melbourne, FL
298[deg] radials; INT Melbourne 298[deg] and Ocala, FL 145[deg]
radials; Ocala; Gators, FL; Greenville, FL; Moultrie, GA; to Macon,
GA.
* * * * *
Issued in Washington, DC, on July 6, 2005.
Edith V. Parish,
Acting Manager, Airspace and Rules.
[FR Doc. 05-13682 Filed 7-11-05; 8:45 am]
BILLING CODE 4910-13-P