Proposed Establishment of High Altitude Area Navigation Routes (RNAV); South Central United States, 56391-56394 [05-19205]
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Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The Federal Aviation
Administration (FAA) amends § 39.13
by adding the following new
airworthiness directive (AD):
Airbus: Docket No. FAA–2005–22524;
Directorate Identifier 2005–NM–135–AD.
Comments Due Date
(a) The FAA must receive comments on
this AD action by October 27, 2005.
Affected ADs
(b) None.
Applicability
(c) This AD applies to Airbus Model A330–
201, –202, –203, –223, –243, –301, –321,
–322, –323, –341, –342, and –343 airplanes;
Model A340–211, –212, –213, –311, –312,
and –313 airplanes; and Model A340–541
and –642 airplanes; certificated in any
category; as identified in Airbus All
Operators Telex (AOT) A330–25A3272–2005,
Revision 01, dated March 24, 2005; Airbus
AOT A340–25A4259–2005, Revision 01;
dated March 24, 2005; or Airbus AOT A340–
25A5091, Revision 02, dated June 1, 2005; as
applicable.
Unsafe Condition
(d) This AD results from a report that an
emergency escape slide/slide raft (referred to
hereafter as a ‘‘slide/raft’’) failed to deploy
properly during a deployment test. We are
issuing this AD to detect and correct
improper routing of the electrical harnesses
of certain slide/rafts, which could prevent
proper deployment of the slide/raft and delay
evacuation of passengers and flightcrew
during an emergency.
Compliance
(e) You are responsible for having the
actions required by this AD performed within
the compliance times specified, unless the
actions have already been done.
Inspections and Corrective Actions
(f) Within 1,700 flight hours after the
effective date of this AD: Inspect certain
crew/passenger doors as required by
paragraph (f)(1) or (f)(2), as applicable, of this
AD to determine if slide/rafts having certain
part numbers (P/N) are installed. A review of
airplane maintenance records is acceptable in
lieu of this inspection if the presence of the
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13:24 Sep 26, 2005
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subject slide/rafts can be conclusively
determined from that review.
(1) For Model A330–201, –202, –203, –223,
–243, –301, –321, –322, –323, –341, –342,
and –343 airplanes and Model A340–211,
–212, –213, –311, –312, and –313 airplanes:
On both right and left hand sides, inspect to
determine the P/N of the slide/rafts of crew/
passenger doors 1 and 4, and, only if it is a
type 1 door, crew/passenger door 3. If crew/
passenger door 3 is not a type 1 door, it is
not subject to any requirement of this AD.
(i) If a slide/raft does not have P/N
7A1508–( ) or 7A1509–( ), no further action
is required for that slide/raft by this AD.
(ii) If a slide/raft has P/N 7A1508–( ) or
7A1509–( ), before further flight, perform a
general visual inspection of the electrical
harness of the slide/raft and reroute the
harness, as applicable, in accordance with
paragraphs 4.2 through 4.2.4 of Airbus All
Operators Telex (AOT) A330–25A3272–2005,
Revision 01, or Airbus AOT A340–25A4259–
2005, Revision 01; both dated March 24,
2005; as applicable.
(2) For Model A340–541 and –642
airplanes: On both right and left hand sides,
inspect to determine the P/N of the slide/rafts
of crew/passenger doors 1 and 4.
(i) If a slide/raft does not have P/N
7A1508–( ), no further action is required for
that slide/raft by this AD.
(ii) If a slide/raft has P/N 7A1508–( ),
before further flight, perform a general visual
inspection of the electrical harness of that
slide/raft and reroute the harness, as
applicable, in accordance with paragraphs
4.2 through 4.2.4 of Airbus AOT A340–
25A5091, Revision 02, dated June 1, 2005.
Note 1: For the purposes of this AD, a
general visual inspection is: ‘‘A visual
examination of an interior or exterior area,
installation, or assembly to detect obvious
damage, failure, or irregularity. This level of
inspection is made from within touching
distance unless otherwise specified. A mirror
may be necessary to ensure visual access to
all surfaces in the inspection area. This level
of inspection is made under normally
available lighting conditions such as
daylight, hangar lighting, flashlight, or
droplight and may require removal or
opening of access panels or doors. Stands,
ladders, or platforms may be required to gain
proximity to the area being checked.’’
Actions Accomplished According to
Previous Issues of AOTs
(g) Actions accomplished before the
effective date of this AD in accordance with
Airbus AOT A330–25A3272, Airbus AOT
A340–25A4259 (for Model A340–200 and
–300 airplanes), or Airbus AOT A340–
25A5091 (for Model A340–541 and –642
airplanes); all dated March 17, 2005; or
A340–25A5091–2005, Revision 01, dated
March 24, 2005; as applicable; are considered
acceptable for compliance with the
corresponding actions specified in paragraph
(f) of this AD.
Alternative Methods of Compliance
(AMOCs)
(h)(1) The Manager, International Branch,
ANM–116, Transport Airplane Directorate,
FAA, has the authority to approve AMOCs
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56391
for this AD, if requested in accordance with
the procedures found in 14 CFR 39.19.
(2) Before using any AMOC approved in
accordance with 14 CFR 39.19 on any
airplane to which the AMOC applies, notify
the appropriate principal inspector in the
FAA Flight Standards Certificate Holding
District Office.
Related Information
(i) French airworthiness directive F–2005–
077, dated May 11, 2005, also addresses the
subject of this AD.
Issued in Renton, Washington, on
September 16, 2005.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 05–19235 Filed 9–26–05; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2005–22398; Airspace
Docket No. 05–ASO–7]
RIN 2120–AA66
Proposed Establishment of High
Altitude Area Navigation Routes
(RNAV); South Central United States
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
SUMMARY: This action proposes to
establish 16 high altitude area
navigation (RNAV) routes in the South
Central United States to support the
High Altitude Redesign (HAR) program.
The FAA is proposing this action to
enhance safety and to improve the
efficient use of the navigable airspace.
DATES: Comments must be received on
or before November 14, 2005.
ADDRESSES: Send comments on this
proposal to the Docket Management
System, U.S. Department of
Transportation, Room Plaza 401, 400
Seventh Street, SW., Washington, DC
20590–0001. You must identify FAA
Docket No. FAA–2005–22398 and
Airspace Docket No. 05–ASO–7, at the
beginning of your comments. You may
also submit comments through the
Internet at https://dms.dot.gov.
FOR FURTHER INFORMATION CONTACT: Paul
Gallant, Airspace and Rules, Office of
System Operations Airspace and AIM,
Federal Aviation Administration, 800
Independence Avenue, SW.,
Washington, DC 20591; telephone: (202)
267–8783.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules
Comments Invited
Interested parties are invited to
participate in this proposed rulemaking
by submitting such written data, views,
or arguments, as they may desire.
Comments that provide the factual basis
supporting the views and suggestions
presented are particularly helpful in
developing reasoned regulatory
decisions on the proposal. Comments
are specifically invited on the overall
regulatory, aeronautical, economic,
environmental, and energy-related
aspects of the proposal.
Communications should identify both
docket numbers (FAA Docket No. FAA–
2005–22398 and Airspace Docket No.
05–ASO–7) and be submitted in
triplicate to the Docket Management
System (see ADDRESSES section for
address and phone number). You may
also submit comments through the
Internet at https://dms.dot.gov.
Commenters wishing the FAA to
acknowledge receipt of their comments
on this action must submit with those
comments a self-addressed, stamped
postcard on which the following
statement is made: ‘‘Comments to FAA
Docket No. FAA–2005–22398 and
Airspace Docket No. 05–ASO–7.’’ The
postcard will be date/time stamped and
returned to the commenter.
All communications received on or
before the specified closing date for
comments will be considered before
taking action on the proposed rule. The
proposal contained in this action may
be changed in light of comments
received. All comments submitted will
be available for examination in the
public docket both before and after the
closing date for comments. A report
summarizing each substantive public
contact with FAA personnel concerned
with this rulemaking will be filed in the
docket.
Availability of NPRM’s
An electronic copy of this document
may be downloaded through the
Internet at https://dms.dot.gov. Recently
published rulemaking documents can
also be accessed through the FAA’s Web
page at https://www.faa.gov, or the
Federal Register’s web page at https://
www.gpoaccess.gov/fr/.
You may review the public docket
containing the proposal, any comments
received, and any final disposition in
person in the Dockets Office (see
ADDRESSES section for address and
phone number) between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. An informal docket
Q–19 PLESS to BNA [New]
PLESS ............................................................
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may also be examined during normal
business hours at the office of the
Regional Air Traffic Division, Federal
Aviation Administration, 1701
Columbia Avenue, College Park, GA
30337.
Persons interested in being placed on
a mailing list for future NPRM’s should
contact the FAA’s Office of Rulemaking,
(202) 267–9677, for a copy of Advisory
Circular No. 11–2A, Notice of Proposed
Rulemaking Distribution System, which
describes the application procedure.
Background
As part of the on-going National
Airspace Redesign, the FAA
implemented the HAR program. The
HAR program’s focus is to develop and
implement fundamental improvements
in navigation structure and operating
methods to allow more flexible and
efficient high altitude en route
operations. In support of this program,
the FAA is establishing new RNAV
routes for use by suitably equipped
aircraft. These new routes would allow
users greater flexibility in route
selection. In addition, users should
achieve economic benefits derived from
less restrictive routing options than are
currently available in the jet route
structure.
These high altitude RNAV routes will
be identified by the letter prefix ‘‘Q,’’
followed by a number consisting of from
one to three digits.
Related Rulemaking
On April 8, 2003, the FAA published
the Designation of Class A, B, C, D, and
E Airspace Areas; Air Traffic Service
Routes, and Reporting Points rule in the
Federal Register (68 FR 16943). The
purpose of the rule was to facilitate the
establishment of RNAV routes in the
National Airspace System (NAS) for use
by aircraft with advanced navigation
system capabilities. This rule adopted
certain amendments proposed in Notice
No. 02–20, Area Navigation and
Miscellaneous Amendments. The rule
revised and adopted several definitions
in FAA regulations, including Air
Traffic Service Routes, to be in concert
with ICAO definitions; and reorganized
the structure of FAA regulations
concerning the designation of Class A,
B, C, D, and E airspace areas, airways,
routes, and reporting points.
The Proposal
The FAA is proposing an amendment
to Title 14 Code of Federal Regulations
(14 CFR) part 71 to establish 16 RNAV
routes in the South Central United
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States within the airspace assigned to
the Memphis Air Route Traffic Control
Center (ARTCC). These routes are
proposed as part of the HAR program to
enhance safety, and to facilitate the
more flexible and efficient use of the
navigable airspace for en route
instrument flight rules (IFR) operations
within the Memphis ARTCC’s area of
responsibility.
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.
Therefore, this proposed 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 proposed 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).
The Proposed Amendment
In consideration of the foregoing, the
Federal Aviation Administration
proposes to amend 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(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 7400.9N,
Airspace Designations and Reporting
Points, dated September 1, 2005 and
effective September 15, 2005, is
amended as follows:
Paragraph 2006—Area Navigation Routes.
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Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules
BNA ...............................................................
*
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Q–21 JONEZ to RZC [New]
JONEZ ............................................................
RZC ................................................................
*
*
Q–23 FSM to RZC [New]
FSM ................................................................
RZC ................................................................
*
*
Q–25 MEEOW to PXV [New]
MEEOW .........................................................
ARG ................................................................
WLSUN ..........................................................
PXV ................................................................
Q–26 ARG to ABROC [New]
ARG ................................................................
ABROC ...........................................................
Q–27 FSM to ZALDA [New]
FSM ................................................................
ZALDA ...........................................................
Q–28 GRAZN to PXV [New]
GRAZN ..........................................................
PYRMD ..........................................................
HAKAT ..........................................................
ESTEE ............................................................
PXV ................................................................
Q–29 HARES to PXV [New]
HARES ...........................................................
MEM ..............................................................
SIDAE ............................................................
PXV ................................................................
Q–30 SQS to VUZ [New]
SQS ................................................................
VUZ ................................................................
Q–31 DHART to PXV [New]
DHART ..........................................................
TOROS ...........................................................
UJM ................................................................
TIIDE ..............................................................
PXV ................................................................
Q–32 ELD to SWAPP [New]
ELD ................................................................
GAGLE ...........................................................
CRAMM .........................................................
BNA ...............................................................
SWAPP ..........................................................
Q–33 PROWL to DHART [New]
PROWL ..........................................................
LIT ..................................................................
DHART ..........................................................
Q–34 TXK to SWAPP [New]
TXK ................................................................
MATIE ...........................................................
MEM ..............................................................
SWAPP ..........................................................
Q–36 RZC to SWAPP [New]
RZC ................................................................
TWITS ............................................................
DEPEC ............................................................
BNA ...............................................................
SWAPP ..........................................................
Q–38 ROKIT to BESOM [New]
ROKIT ............................................................
INCIN .............................................................
LAREY ...........................................................
BESOM ..........................................................
Q–40 AEX to MISLE [New]
AEX ................................................................
DOOMS ..........................................................
SALVA ...........................................................
MISLE ............................................................
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(Lat. 34°30′57″ N., long. 95°27′34″ W.)
(Lat. 36°14′47″ N., long. 94°07′17″ W.)
VORTAC ........................................................
VORTAC ........................................................
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(Lat. 36°14′47″ N., long. 94°07′17″ W.)
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WP .................................................................
VORTAC ........................................................
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(Lat.
(Lat.
(Lat.
VORTAC ........................................................
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(Lat. 36°06′36″ N., long. 90°57′13″ W.)
(Lat. 34°37′05″ N., long. 87°26′07″ W.)
VORTAC ........................................................
WP .................................................................
(Lat. 35°23′18″ N., long. 94°16′18″ W.)
(Lat. 36°04′55″ N., long. 93°37′37″ W.)
WP .................................................................
WP .................................................................
WP .................................................................
WP .................................................................
VORTAC ........................................................
(Lat.
(Lat.
(Lat.
(Lat.
(Lat.
34°15′00″
34°34′00″
36°17′00″
37°41′00″
37°55′42″
WP .................................................................
VORTAC ........................................................
WP .................................................................
VORTAC ........................................................
(Lat.
(Lat.
(Lat.
(Lat.
33°00″00″ N., long. 91°44′00″ W.)
35°00′54″ N., long. 89°59′00″ W.)
37°20′00″ N., long. 87°50′00″ W.)
37°55′42″ N., long. 87°45′45″ W.)
VORTAC ........................................................
VORTAC ........................................................
(Lat. 33°27′50″ N., long. 90°16′38″ W.)
(Lat. 33°40′13″ N., long. 86°53′59″ W.)
Fix ..................................................................
WP .................................................................
VOR/DME ......................................................
WP .................................................................
VORTAC ........................................................
(Lat.
(Lat.
(Lat.
(Lat.
(Lat.
33°23′52″
33°40′00″
34°34′30″
37°28′00″
37°55′42″
N.,
N.,
N.,
N.,
N.,
long.
long.
long.
long.
long.
92°25′10″
92°10′00″
90°40′28″
87°59′00″
87°45′45″
W.)
W.)
W.)
W.)
W.)
VORTAC ........................................................
WP .................................................................
Fix ..................................................................
VORTAC ........................................................
Fix ..................................................................
(Lat.
(Lat.
(Lat.
(Lat.
(Lat.
33°15′22″
34°08′00″
34°38′11″
36°08′13″
36°36′50″
N.,
N.,
N.,
N.,
N.,
long.
long.
long.
long.
long.
92°44′38″
90°17′00″
88°53′55″
86°41′05″
85°10′56″
W.)
W.)
W.)
W.)
W.)
WP .................................................................
VORTAC ........................................................
Fix ..................................................................
(Lat. 37°02′00″ N., long. 91°15′00″ W.)
(Lat. 34°40′40″ N., long. 92°10′50″ W.)
(Lat. 33°23′52″ N., long. 92°25′10″ W.)
VORTAC ........................................................
Fix ..................................................................
VORTAC ........................................................
Fix ..................................................................
(Lat.
(Lat.
(Lat.
(Lat.
33°30′50″
34°05′42″
35°00′54″
36°36′50″
N.,
N.,
N.,
N.,
long.
long.
long.
long.
94°04′24″
92°33′02″
89°59′00″
85°10′56″
W.)
W.)
W.)
W.)
VORTAC ........................................................
WP .................................................................
WP .................................................................
VORTAC ........................................................
Fix ..................................................................
(Lat.
(Lat.
(Lat.
(Lat.
(Lat.
36°14′47″
36°08′32″
36°06′00″
36°08′13″
36°36′50″
N.,
N.,
N.,
N.,
N.,
long.
long.
long.
long.
long.
94°07′17″
90°54′48″
87°31′00″
86°41′05″
86°10′56″
W.)
W.)
W.)
W.)
W.)
Fix
WP
WP
Fix
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(Lat.
(Lat.
(Lat.
(Lat.
30°29′50″
31°21′09″
32°00′12″
33°35′11″
N.,
N.,
N.,
N.,
long.
long.
long.
long.
94°30′50″
92°45′18″
91°22′22″
87°39′23″
W.)
W.)
W.)
W.)
VORTAC ........................................................
WP .................................................................
WP .................................................................
WP .................................................................
(Lat.
(Lat.
(Lat.
(Lat.
31°15′24″
31°53′08″
32°38′00″
33°24′00″
N.,
N.,
N.,
N.,
long.
long.
long.
long.
92°30′04″
91°09′56″
89°21′56″
87°38′00″
W.)
W.)
W.)
W.)
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93°31′25″
90°57′13″
88°08′00″
87°45′45″
94°21′29″
93°44′00″
91°04′00″
88°17′00″
87°45′45″
W.)
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56394
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Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules
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Issued in Washington, DC, on September
19, 2005.
Edith V. Parish,
Acting Manager, Airspace and Rules.
[FR Doc. 05–19205 Filed 9–26–05; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 20, 510, 514, and 516
[Docket No. 2005N–0329]
RIN 0910–AF60
Designation of New Animal Drugs for
Minor Uses or Minor Species
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
SUMMARY: The Minor Use and Minor
Species Animal Health Act of 2004
(MUMS act) amended the Federal Food,
Drug, and Cosmetic Act (the act) to
establish new regulatory procedures that
provide incentives intended to make
more drugs legally available to
veterinarians and animal owners for the
treatment of minor animal species and
uncommon diseases in major animal
species. At this time, FDA is issuing
proposed regulations to implement the
act. These regulations propose
procedures for designating a new animal
drug as a minor use or minor species
drug. Such designation establishes
eligibility for the incentives provided by
the MUMS act.
DATES: Submit written or electronic
comments on this document by
December 12, 2005. Submit comments
on the information collection provisions
by October 27, 2005.
ADDRESSES: You may submit comments,
identified by Docket No. 2005N–0329
and/or RIN number 0910–AF60, by any
of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
VerDate Aug<31>2005
13:24 Sep 26, 2005
Jkt 205001
• FAX: 301-827-6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure timely processing of
electronic comments, FDA is no longer
accepting comments submitted to the
agency by e-mail. FDA encourages you
to continue to submit electronic
comments by using the Federal
eRulemaking Portal and agency Web
site, as described in the Electronic
Submissions portion of this paragraph.
Instructions: All submissions received
must include the agency name and
docket number or regulatory
information number for this rulemaking.
All comments received may be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
detailed instructions on submitting
comments and additional information
on the rulemaking process, see the
‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
number found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Andrew Beaulieu, Center for Veterinary
Medicine (HFV–50), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9090, email: Andrew.Beaulieu@fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In enacting the MUMS act (Public
Law 108–282), Congress sought to
encourage the development of animal
drugs that are currently unavailable to
minor species (species other than cattle,
horses, swine, chickens, turkeys, dogs,
and cats) in the United States or to
major species afflicted with uncommon
diseases or conditions (minor uses).
Congress recognized that the markets for
drugs intended to treat these species,
diseases, or conditions are so small that
there are often insufficient economic
incentives to motivate sponsors to
develop data to support approvals.
Further, Congress recognized that some
minor species populations are too small
or their management systems too
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
diverse to make it practical to conduct
traditional studies to demonstrate safety
and effectiveness of these animal drugs.
As a result of these limitations, sponsors
have generally not been willing or able
to collect data to support legal
marketing of drugs for these species,
diseases, or conditions. Consequently,
Congress enacted the MUMS act, which
amended the Federal Food, Drug, and
Cosmetic Act (the act) to provide
incentives to develop new animal drugs
for minor species and minor uses, while
still ensuring appropriate safeguards for
animal and human health.
At this time, FDA is issuing proposed
regulations to implement section 573 of
the act (21 U.S.C. 360ccc-2). These
regulations propose procedures for
designating a new animal drug as a
minor use or minor species drug. Such
designation provides eligibility for
certain incentives established by the
MUMS act, including exclusive
marketing rights associated with the
conditional approval or approval of
designated new animal drugs and for
grants to support designated new animal
drug development. In accordance with
section 573 of the act, these proposed
regulations provide for designation of a
new animal drug to be granted only
when the drug is intended for a minor
use or use in a minor species and only
when the same new animal drug, in the
same dosage form, for the same
intended use is not already approved
under section 512 of the act (21 U.S.C.
360b), conditionally approved under
section 571 of the act (21 U.S.C. 360ccc),
or designated under section 573 of the
act at the time that a sponsor requests
designation.
The incentives in the MUMS act and
these proposed regulations are modeled
on those provided by the human orphan
drug program. These incentives include
the following: (1) Eligibility for grants
and contracts to defray the costs of
qualified safety and effectiveness testing
expenses and manufacturing expenses
incurred in the development of
designated new animal drugs and (2) a
7-year period of exclusive marketing
rights to enable sponsors to recover
costs of drug development without
competition. Marketing exclusivity for
nondesignated drugs is limited to 3 or
5 years of protection from generic
copying (section 512(c)(2)(F) of the act).
The exclusive marketing rights for
designated drugs provide protection
from generic copying and from approval
of another pioneer application for the
same drug, in the same dosage form, for
the same intended use.
Other major incentives of the MUMS
act include the following: (1)
Conditional approval, which is
E:\FR\FM\27SEP1.SGM
27SEP1
]]>Agencies
[Federal Register Volume 70, Number 186 (Tuesday, September 27, 2005)]
[Proposed Rules]
[Pages 56391-56394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19205]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2005-22398; Airspace Docket No. 05-ASO-7]
RIN 2120-AA66
Proposed Establishment of High Altitude Area Navigation Routes
(RNAV); South Central United States
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This action proposes to establish 16 high altitude area
navigation (RNAV) routes in the South Central United States to support
the High Altitude Redesign (HAR) program. The FAA is proposing this
action to enhance safety and to improve the efficient use of the
navigable airspace.
DATES: Comments must be received on or before November 14, 2005.
ADDRESSES: Send comments on this proposal to the Docket Management
System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh
Street, SW., Washington, DC 20590-0001. You must identify FAA Docket
No. FAA-2005-22398 and Airspace Docket No. 05-ASO-7, at the beginning
of your comments. You may also submit comments through the Internet at
https://dms.dot.gov.
FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace and Rules,
Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone: (202) 267-8783.
SUPPLEMENTARY INFORMATION:
[[Page 56392]]
Comments Invited
Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No.
FAA-2005-22398 and Airspace Docket No. 05-ASO-7) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at https://dms.dot.gov.
Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2005-22398 and Airspace Docket No. 05-ASO-7.''
The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.
Availability of NPRM's
An electronic copy of this document may be downloaded through the
Internet at https://dms.dot.gov. Recently published rulemaking documents
can also be accessed through the FAA's Web page at https://www.faa.gov,
or the Federal Register's web page at https://www.gpoaccess.gov/fr/
index.html.
You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Regional Air Traffic Division, Federal Aviation
Administration, 1701 Columbia Avenue, College Park, GA 30337.
Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.
Background
As part of the on-going National Airspace Redesign, the FAA
implemented the HAR program. The HAR program's focus is to develop and
implement fundamental improvements in navigation structure and
operating methods to allow more flexible and efficient high altitude en
route operations. In support of this program, the FAA is establishing
new RNAV routes for use by suitably equipped aircraft. These new routes
would allow users greater flexibility in route selection. In addition,
users should achieve economic benefits derived from less restrictive
routing options than are currently available in the jet route
structure.
These high altitude RNAV routes will be identified by the letter
prefix ``Q,'' followed by a number consisting of from one to three
digits.
Related Rulemaking
On April 8, 2003, the FAA published the Designation of Class A, B,
C, D, and E Airspace Areas; Air Traffic Service Routes, and Reporting
Points rule in the Federal Register (68 FR 16943). The purpose of the
rule was to facilitate the establishment of RNAV routes in the National
Airspace System (NAS) for use by aircraft with advanced navigation
system capabilities. This rule adopted certain amendments proposed in
Notice No. 02-20, Area Navigation and Miscellaneous Amendments. The
rule revised and adopted several definitions in FAA regulations,
including Air Traffic Service Routes, to be in concert with ICAO
definitions; and reorganized the structure of FAA regulations
concerning the designation of Class A, B, C, D, and E airspace areas,
airways, routes, and reporting points.
The Proposal
The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to establish 16 RNAV routes in the South
Central United States within the airspace assigned to the Memphis Air
Route Traffic Control Center (ARTCC). These routes are proposed as part
of the HAR program to enhance safety, and to facilitate the more
flexible and efficient use of the navigable airspace for en route
instrument flight rules (IFR) operations within the Memphis ARTCC's
area of responsibility.
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.
Therefore, this proposed 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 proposed 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).
The Proposed Amendment
In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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(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
7400.9N, Airspace Designations and Reporting Points, dated September 1,
2005 and effective September 15, 2005, is amended as follows:
Paragraph 2006--Area Navigation Routes.
* * * * *
Q-19 PLESS to BNA [New]
PLESS....................... Fix................. (Lat. 37[deg]48'35'' N., long. 88[deg]57'48'' W.)
[[Page 56393]]
BNA......................... VORTAC.............. (Lat. 36[deg]08'13'' N., long. 86[deg]41'05'' W.)
* * * * * * *
Q-21 JONEZ to RZC [New]
JONEZ....................... Fix................. (Lat. 34[deg]30'57'' N., long. 95[deg]27'34'' W.)
RZC......................... VORTAC.............. (Lat. 36[deg]14'47'' N., long. 94[deg]07'17'' W.)
* * * * * * *
Q-23 FSM to RZC [New]
FSM......................... VORTAC.............. (Lat. 35[deg]23'18'' N., long. 94[deg]16'18'' W.)
RZC......................... VORTAC.............. (Lat. 36[deg]14'47'' N., long. 94[deg]07'17'' W.)
* * * * * * *
Q-25 MEEOW to PXV [New]
MEEOW....................... Fix................. (Lat. 34[deg]19'05'' N., long. 93[deg]31'25'' W.)
ARG......................... VORTAC.............. (Lat. 36[deg]06'36'' N., long. 90[deg]57'13'' W.)
WLSUN....................... WP.................. (Lat. 37[deg]35'00'' N., long. 88[deg]08'00'' W.)
PXV......................... VORTAC.............. (Lat. 37[deg]55'42'' N., long. 87[deg]45'45'' W.)
Q-26 ARG to ABROC [New]
ARG......................... VORTAC.............. (Lat. 36[deg]06'36'' N., long. 90[deg]57'13'' W.)
ABROC....................... Fix................. (Lat. 34[deg]37'05'' N., long. 87[deg]26'07'' W.)
Q-27 FSM to ZALDA [New]
FSM......................... VORTAC.............. (Lat. 35[deg]23'18'' N., long. 94[deg]16'18'' W.)
ZALDA....................... WP.................. (Lat. 36[deg]04'55'' N., long. 93[deg]37'37'' W.)
Q-28 GRAZN to PXV [New]
GRAZN....................... WP.................. (Lat. 34[deg]15'00'' N., long. 94[deg]21'29'' W.)
PYRMD....................... WP.................. (Lat. 34[deg]34'00'' N., long. 93[deg]44'00'' W.)
HAKAT....................... WP.................. (Lat. 36[deg]17'00'' N., long. 91[deg]04'00'' W.)
ESTEE....................... WP.................. (Lat. 37[deg]41'00'' N., long. 88[deg]17'00'' W.)
PXV......................... VORTAC.............. (Lat. 37[deg]55'42'' N., long. 87[deg]45'45'' W.)
Q-29 HARES to PXV [New]
HARES....................... WP.................. (Lat. 33[deg]00''00'' N., long. 91[deg]44'00'' W.)
MEM......................... VORTAC.............. (Lat. 35[deg]00'54'' N., long. 89[deg]59'00'' W.)
SIDAE....................... WP.................. (Lat. 37[deg]20'00'' N., long. 87[deg]50'00'' W.)
PXV......................... VORTAC.............. (Lat. 37[deg]55'42'' N., long. 87[deg]45'45'' W.)
Q-30 SQS to VUZ [New]
SQS......................... VORTAC.............. (Lat. 33[deg]27'50'' N., long. 90[deg]16'38'' W.)
VUZ......................... VORTAC.............. (Lat. 33[deg]40'13'' N., long. 86[deg]53'59'' W.)
Q-31 DHART to PXV [New]
DHART....................... Fix................. (Lat. 33[deg]23'52'' N., long. 92[deg]25'10'' W.)
TOROS....................... WP.................. (Lat. 33[deg]40'00'' N., long. 92[deg]10'00'' W.)
UJM......................... VOR/DME............. (Lat. 34[deg]34'30'' N., long. 90[deg]40'28'' W.)
TIIDE....................... WP.................. (Lat. 37[deg]28'00'' N., long. 87[deg]59'00'' W.)
PXV......................... VORTAC.............. (Lat. 37[deg]55'42'' N., long. 87[deg]45'45'' W.)
Q-32 ELD to SWAPP [New]
ELD......................... VORTAC.............. (Lat. 33[deg]15'22'' N., long. 92[deg]44'38'' W.)
GAGLE....................... WP.................. (Lat. 34[deg]08'00'' N., long. 90[deg]17'00'' W.)
CRAMM....................... Fix................. (Lat. 34[deg]38'11'' N., long. 88[deg]53'55'' W.)
BNA......................... VORTAC.............. (Lat. 36[deg]08'13'' N., long. 86[deg]41'05'' W.)
SWAPP....................... Fix................. (Lat. 36[deg]36'50'' N., long. 85[deg]10'56'' W.)
Q-33 PROWL to DHART [New]
PROWL....................... WP.................. (Lat. 37[deg]02'00'' N., long. 91[deg]15'00'' W.)
LIT......................... VORTAC.............. (Lat. 34[deg]40'40'' N., long. 92[deg]10'50'' W.)
DHART....................... Fix................. (Lat. 33[deg]23'52'' N., long. 92[deg]25'10'' W.)
Q-34 TXK to SWAPP [New]
TXK......................... VORTAC.............. (Lat. 33[deg]30'50'' N., long. 94[deg]04'24'' W.)
MATIE....................... Fix................. (Lat. 34[deg]05'42'' N., long. 92[deg]33'02'' W.)
MEM......................... VORTAC.............. (Lat. 35[deg]00'54'' N., long. 89[deg]59'00'' W.)
SWAPP....................... Fix................. (Lat. 36[deg]36'50'' N., long. 85[deg]10'56'' W.)
Q-36 RZC to SWAPP [New]
RZC........................ VORTAC.............. (Lat. 36[deg]14'47'' N., long. 94[deg]07'17'' W.)
TWITS....................... WP.................. (Lat. 36[deg]08'32'' N., long. 90[deg]54'48'' W.)
DEPEC....................... WP.................. (Lat. 36[deg]06'00'' N., long. 87[deg]31'00'' W.)
BNA......................... VORTAC.............. (Lat. 36[deg]08'13'' N., long. 86[deg]41'05'' W.)
SWAPP....................... Fix................. (Lat. 36[deg]36'50'' N., long. 86[deg]10'56'' W.)
Q-38 ROKIT to BESOM [New]
ROKIT....................... Fix................. (Lat. 30[deg]29'50'' N., long. 94[deg]30'50'' W.)
INCIN....................... WP.................. (Lat. 31[deg]21'09'' N., long. 92[deg]45'18'' W.)
LAREY....................... WP.................. (Lat. 32[deg]00'12'' N., long. 91[deg]22'22'' W.)
BESOM....................... Fix................. (Lat. 33[deg]35'11'' N., long. 87[deg]39'23'' W.)
Q-40 AEX to MISLE [New]
AEX......................... VORTAC.............. (Lat. 31[deg]15'24'' N., long. 92[deg]30'04'' W.)
DOOMS....................... WP.................. (Lat. 31[deg]53'08'' N., long. 91[deg]09'56'' W.)
SALVA....................... WP.................. (Lat. 32[deg]38'00'' N., long. 89[deg]21'56'' W.)
MISLE....................... WP.................. (Lat. 33[deg]24'00'' N., long. 87[deg]38'00'' W.)
[[Page 56394]]
* * * * *
Issued in Washington, DC, on September 19, 2005.
Edith V. Parish,
Acting Manager, Airspace and Rules.
[FR Doc. 05-19205 Filed 9-26-05; 8:45 am]
BILLING CODE 4910-13-P
