New Animal Drugs; Gentamicin and Betamethasone Spray, 22821-22822 [E9-11368]
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Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Rules and Regulations
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2008–1139; Airspace
Docket No. 08–ASW–23]
Amendment of Class E Airspace;
Coleman, TX
AGENCY: Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
SUMMARY: This action amends Class E
airspace at Coleman, TX. Additional
controlled airspace is necessary to
accommodate Area Navigation (RNAV)
Standard Instrument Approach
Procedures (SIAP) at Coleman
Municipal Airport, Coleman, TX. The
FAA is taking this action to enhance the
safety and management of Instrument
Flight Rule (IFR) operations at Coleman
Municipal Airport.
DATES: Effective Date: 0901 UTC, July 2,
2009. The Director of the Federal
Register approves this incorporation by
reference action under 1 CFR Part 51,
subject to the annual revision of FAA
Order 7400.9 and publication of
conforming amendments.
FOR FURTHER INFORMATION CONTACT:
Scott Enander, Central Service Center,
Operations Support Group, Federal
Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort
Worth, TX 76193–0530; telephone (817)
321–7716.
SUPPLEMENTARY INFORMATION:
History
On February 24, 2009, the FAA
published in the Federal Register a
notice of proposed rulemaking to amend
Class E airspace at Coleman, TX, adding
additional controlled airspace at
Coleman Municipal Airport, Coleman,
TX (74 FR 8219, Docket No. FAA–2008–
1139). Interested parties were invited to
participate in this rulemaking effort by
submitting written comments on the
proposal to the FAA. No comments
were received. Class E airspace
designations are published in paragraph
6005 of FAA Order 7400.9S signed
October 3, 2008, and effective October
31, 2008, 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 Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) Part 71 by
amending Class E airspace at Coleman,
TX, adding additional controlled
VerDate Nov<24>2008
14:00 May 14, 2009
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airspace at Coleman Municipal Airport,
Coleman, TX, for the safety and
management of IFR operations.
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 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 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 adds
additional controlled airspace at
Coleman Municipal Airport, Coleman,
TX.
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:
■
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.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9S, Airspace
■
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
22821
Designations and Reporting Points,
signed October 3, 2008, and effective
October 31, 2008, is amended as
follows:
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface.
*
*
*
*
*
ASW TX E5 Coleman, TX [Amended]
Coleman Municipal Airport, TX
(Lat. 31°50′32″ N., long. 99°24′14″ W.)
That airspace extending upward from 700
feet above the surface within an 8-mile radius
of Coleman Municipal Airport.
*
*
*
*
*
Issued in Fort Worth, TX, on April 22,
2009.
Roger M. Trevino,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. E9–11259 Filed 5–14–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Gentamicin and
Betamethasone Spray
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
original approval of an abbreviated new
animal drug application (ANADA) filed
by American Pharmaceuticals and
Cosmetics, Inc. The ANADA provides
for the veterinary prescription use of
gentamicin sulfate and betamethasone
valerate topical spray in dogs.
DATES: This rule is effective May 15,
2009.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: American
Pharmaceuticals and Cosmetics, Inc.,
1401 Joel East Rd., Fort Worth, TX
76140, filed ANADA 200–388 that
provides for veterinary prescription use
of GB (gentamicin sulfate and
betamethasone valerate) Topical Spray
in dogs. American Pharmaceuticals and
Cosmetics, Inc.’s GB Topical Spray is
E:\FR\FM\15MYR1.SGM
15MYR1
22822
Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Rules and Regulations
approved as a generic copy of ScheringPlough Animal Health Corp.’s
GENTOCIN Topical Spray, approved
under NADA 132–338. The ANADA is
approved as of April 7, 2009, and the
regulations are amended in 21 CFR
524.1044f to reflect the approval.
In addition, American
Pharmaceuticals and Cosmetics, Inc., is
not currently listed in the animal drug
regulations as a sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to add
entries for this sponsor.
In accordance with the freedom of
information 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.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does 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 510
paragraph (c)(2), numerically add an
entry for ‘‘065531’’ to read as follows:
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
American Pharmaceuticals
and Cosmetics, Inc.,
1401 Joel East Rd., Fort
Worth, TX 76140
*
*
*
Drug labeler
code
*
*
065531
*
*
(2) * * *
Drug labeler
code
*
065531
*
*
*
Firm name and address
*
*
*
American Pharmaceuticals
and Cosmetics, Inc.,
1401 Joel East Rd., Fort
Worth, TX 76140
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1044f
[Amended]
4. In § 524.1044f, in paragraph (b),
remove ‘‘and 058829’’ and in its place
add ‘‘058829, and 065531’’.
■
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Dated: May 8, 2009.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. E9–11368 Filed 5–14–09; 8:45 am]
21 CFR Part 524
BILLING CODE 4160–01–S
Animal drugs.
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 510 and 524 are amended as
follows:
■
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘American Pharmaceuticals
and Cosmetics, Inc.’’; and in the table in
■
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14:00 May 14, 2009
Jkt 217001
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 3500
[Docket No. FR–5180–F–06]
RIN 2502–AI61
Real Estate Settlement Procedures Act
(RESPA): Rule To Simplify and
Improve the Process of Obtaining
Mortgages and Reduce Consumer
Settlement Costs; Withdrawal of
Revised Definition of ‘‘Required Use’’
AGENCY: Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
ACTION:
Final rule.
SUMMARY: This final rule withdraws the
revisions to the definition of ‘‘required
use’’ as provided in HUD’s November
17, 2008, final rule amending its Real
Estate Settlement Procedures Act
(RESPA) regulations. The November 17,
2008, final rule, in part, revised the
existing definition of ‘‘required use,’’ for
the purpose of enhancing protections for
consumers from deceptive mortgage
practices that result from certain
affiliated business transactions. The
revised definition of ‘‘required use’’ had
been scheduled to become effective on
January 16, 2009. On January 15, 2009,
and March 10, 2009, HUD published
final rules delaying the effective date of
the definition of ‘‘required use.’’ The
March 10, 2009, final rule provides for
an effective date of July 16, 2009. The
March 10, 2009, rule also solicited
comment on whether HUD should
withdraw the revised definition of
‘‘required use’’ and, if so, whether HUD
should initiate new rulemaking on the
subject. HUD has taken into
consideration the public comments
received and has decided to withdraw
the revised ‘‘required use’’ definition.
HUD therefore leaves in place the
definition of ‘‘required use’’ before the
revisions made by the November 17,
2008, final rule. HUD remains
committed to the RESPA reform goals of
the November 17, 2008, final rule and
concerned about some of the practices
reported by commenters, and will
initiate a new rulemaking process on
required use.
DATES: Effective Date: June 15, 2009,
except the amendment to 24 CFR
3500.2, which is effective July 16, 2009.
FOR FURTHER INFORMATION CONTACT: Ivy
Jackson, Director, or Barton Shapiro,
Deputy Director, Office of RESPA and
Interstate Land Sales, Office of Housing,
Department of Housing and Urban
Development, 451 7th Street, SW.,
Room 9158, Washington, DC 20410–
8000; telephone 202–708–0502 (this is
not a toll-free telephone number).
Persons with hearing or speech
impairments may access this number
through TTY by calling the toll-free
Federal Information Relay Service at
800–877–8339.
SUPPLEMENTARY INFORMATION:
I. Background
On November 17, 2008 (73 FR 68204),
HUD published a final rule amending its
regulations in 24 CFR part 3500 to
further the purposes of the Real Estate
Settlement Procedures Act of 1974 (12
U.S.C. 2601–2617) by requiring more
timely and effective disclosures related
E:\FR\FM\15MYR1.SGM
15MYR1
]]>Agencies
[Federal Register Volume 74, Number 93 (Friday, May 15, 2009)]
[Rules and Regulations]
[Pages 22821-22822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11368]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Gentamicin and Betamethasone Spray
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the original approval of an abbreviated new
animal drug application (ANADA) filed by American Pharmaceuticals and
Cosmetics, Inc. The ANADA provides for the veterinary prescription use
of gentamicin sulfate and betamethasone valerate topical spray in dogs.
DATES: This rule is effective May 15, 2009.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: American Pharmaceuticals and Cosmetics,
Inc., 1401 Joel East Rd., Fort Worth, TX 76140, filed ANADA 200-388
that provides for veterinary prescription use of GB (gentamicin sulfate
and betamethasone valerate) Topical Spray in dogs. American
Pharmaceuticals and Cosmetics, Inc.'s GB Topical Spray is
[[Page 22822]]
approved as a generic copy of Schering-Plough Animal Health Corp.'s
GENTOCIN Topical Spray, approved under NADA 132-338. The ANADA is
approved as of April 7, 2009, and the regulations are amended in 21 CFR
524.1044f to reflect the approval.
In addition, American Pharmaceuticals and Cosmetics, Inc., is not
currently listed in the animal drug regulations as a sponsor of an
approved application. Accordingly, 21 CFR 510.600(c) is being amended
to add entries for this sponsor.
In accordance with the freedom of information 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.
The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does 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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 524
Animal drugs.
0
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 510 and
524 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``American Pharmaceuticals and Cosmetics, Inc.''; and
in the table in paragraph (c)(2), numerically add an entry for
``065531'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
American Pharmaceuticals and Cosmetics, 065531
Inc., 1401 Joel East Rd., Fort Worth, TX
76140
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
065531 American Pharmaceuticals and Cosmetics,
Inc., 1401 Joel East Rd., Fort Worth, TX
76140
* * * * *
------------------------------------------------------------------------
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1044f [Amended]
0
4. In Sec. 524.1044f, in paragraph (b), remove ``and 058829'' and in
its place add ``058829, and 065531''.
Dated: May 8, 2009.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E9-11368 Filed 5-14-09; 8:45 am]
BILLING CODE 4160-01-S
