New Animal Drugs; Change of Sponsor's Drug Labeler Code, 13541-13543 [06-2554]
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Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Rules and Regulations
Note: Cessna Caravan Service Bulletin No.
CAB04–9, dated October 4, 2004, also
addresses the installation of the pilot assist
handle.
May I Request an Alternative Method of
Compliance?
(f) The Manager, Wichita Aircraft
Certification Office (ACO), FAA, has the
authority to approve alternative methods of
compliance for this AD, if requested using
the procedures found in 14 CFR 39.19. For
information on any already approved
alternative methods of compliance, contact
Paul Pellicano, Aerospace Engineer (Icing),
FAA, Small Airplane Directorate, c/o Atlanta
ACO, One Crown Center, 1985 Phoenix
Boulevard, Suite 450, Atlanta, GA 30349;
telephone: (770) 703–6064; facsimile: (770)
703–6097; or Robert P. Busto, Aerospace
Engineer, Wichita ACO, FAA, 1801 Airport
Road, Wichita, Kansas 67209; telephone:
(316) 946–4157; facsimile: (316) 946–4107.
Does This AD Incorporate Any Material by
Reference?
(g) You must do the actions required by
this AD following the instructions in Cessna
Caravan Service Kit No. SK208–146, dated
October 4, 2004, and Cessna Caravan
Accessory Kit No. AK208–6C, Revision C,
dated August 27, 1993.
(1) On February 22, 2006 (71 FR 1941,
January 12, 2006), and in accordance with 5
U.S.C. 552(a) and 1 CFR part 51, the Director
of the Federal Register previously approved
the incorporation by reference of Cessna
Caravan Service Kit No. SK208–146, dated
October 4, 2004, and Cessna Caravan
Accessory Kit No. AK208–6C, Revision C,
dated August 27, 1993.
(2) To get a copy of this service
information, contact The Cessna Aircraft
Company, Product Support, P.O. Box 7706,
Wichita, Kansas 67277–7706; telephone:
(316) 517–5800; facsimile: (316) 942–9006.
To review copies of this service information,
go to the National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, go
to: https://www.archives.gov/federal_register/
code_of_federal_regulations/
ibr_locations.html or call (202) 741–6030. To
view the AD docket, go to the Docket
Management Facility; U.S. Department of
Transportation, 400 Seventh Street, SW.,
Nassif Building, Room PL–401, Washington,
DC 20590–001 or on the Internet at https://
dms.dot.gov. The docket number is FAA–
2005–21275; Directorate Identifier 2005–CE–
28–AD.
HSROBINSON on PROD1PC70 with RULES
Appendix 1 to AD 2006–01–11 R1
Changes to the Cessna Models 208 or
208B Pilot’s Operating Handbook (POH)
and FAA-Approved Airplane Flight
Manual
Affected Cessna Models 208 or 208B Pilot’s
Operating Handbook (POH) and FAAApproved Airplane Flight Manual (AFM)
Insert the following text after the ‘‘OTHER
LIMITATIONS’’ in the LIMITATIONS section
of the Cessna Models 208 or 208B Pilot’s
Operating Handbook (POH) and FAAApproved Airplane Flight Manual (AFM):
COLD WEATHER OPERATIONS.
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14:40 Mar 15, 2006
Jkt 208001
The airplane must be equipped with the
following equipment when operating at an
airport in the ground icing conditions
defined under ‘‘Visual/Tactile Check’’ in the
LIMITATIONS section:
1. Pilot assist handle, Cessna P/N SK208–
146–2 (or FAA-approved equivalent part
number).
Appendix 2 to AD 2006–01–11 R1
Changes to the Cessna Models 208 or
208B Pilot’s Operating Handbook (POH)
and FAA-Approved Airplane Flight
Manual
Affected Cessna Models 208 or 208B Pilot’s
Operating Handbook (POH) and FAAApproved Airplane Flight Manual (AFM)
Add the following to the equipment listed
under ‘‘FLIGHT INTO KNOWN ICING’’ in
the ‘‘KINDS OF OPERATION LIMITS’’ in the
LIMITATIONS section of the FAA-Approved
Airplane Flight Manual:
Lower main landing gear leading edge deice
boots
Cargo pod nosecap deice boot
Appendix 3 to AD 2006–01–11 R1
Changes to the Cessna Models 208 or
208B Pilot’s Operating Handbook (POH)
and FAA-Approved Airplane Flight
Manual Supplement S1
Affected Cessna Models 208 or 208B Pilot’s
Operating Handbook (POH) and FAAApproved Airplane Flight Manual (AFM)
Supplement S1
Remove the paragraph under ‘‘REQUIRED
EQUIPMENT’’ in the Limitations section of
the FAA-Approved Flight Manual
Supplement S1 ‘‘Known Icing Equipment’’,
that currently reads as follows:
‘‘The following additional equipment is
not required for flight into icing conditions
as defined by FAR 25, but may be installed
on early serial airplanes by using optional
accessory Kit AK208–6. On later serial
airplanes, this equipment may be included
with the flight into known icing package. If
installed, this equipment must be fully
operational:’’
Issued in Kansas City, Missouri, on March
10, 2006.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft
Certification Service.
[FR Doc. 06–2546 Filed 3–15–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and
529
New Animal Drugs; Change of
Sponsor’s Drug Labeler Code
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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13541
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of drug labeler code for MedPharmex, Inc.
DATES: This rule is effective March 16,
2006.
FOR FURTHER INFORMATION CONTACT:
Charles Eastin, Center for Veterinary
Medicine (HFV–210), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9077, email: charles.eastin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has
found that the animal drug regulations
do not reflect the correct drug labeler
code for Med-Pharmex, Inc.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600,
520.1044a, 520.1195, 520.1484,
520.1485, 520.2220a, 520.2345d,
522.900, 524.1044b, 524.1044f,
524.1044g, 524.1193, 524.1443,
524.1580b, 524.1580e, 524.1600a,
524.2481, and 529.1044b to correct this
error. In addition, 21 CFR 524.1044b,
524.1044f, 524.1443, and 524.2481 are
being revised to reflect a current format.
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 Parts 520, 522, 524, and 529
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, 520, 522, 524, and 529
are amended as follows:
I
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. Amend § 510.600 in the table in
paragraph (c)(1) in the entry for ‘‘MedPharmex, Inc.’’ by removing ‘‘051259’’
and by adding in its place ‘‘054925’’;
and in the table in paragraph (c)(2) by
removing the entry for ‘‘051259’’ and by
I
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13542
Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Rules and Regulations
§ 522.900
numerically adding a new entry for
‘‘054925’’ to read as follows:
*
*
(c) * * *
(2) * * *
*
Drug labeler
code
*
*
*
12. The authority citation for 21 CFR
part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
13. Revise § 524.1044b to read as
follows:
I
*
*
*
Med-Pharmex, Inc., 2727
Thompson Creek Rd.,
Pomona, CA 91767–
1861
*
*
*
§ 524.1044b Gentamicin sulfate,
betamethasone valerate otic solution.
(a) Specifications. Each milliliter of
solution contains gentamicin sulfate
equivalent to 3 milligrams (mg)
gentamicin base and betamethasone
valerate equivalent to 1 mg
betamethasone alcohol.
(b) Sponsors. See Nos. 000061 and
054925 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amounts
and indications for use—(i) For the
treatment of acute and chronic otitis
externa caused by bacteria sensitive to
gentamicin in dogs, instill three to eight
drops of solution into the ear canal
twice daily for 7 to 14 days.
(ii) For the treatment of infected
superficial lesions caused by bacteria
sensitive to gentamicin in dogs and cats,
apply a sufficient amount of the drug to
cover the treatment area twice daily for
7 to 14 days.
(2) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
I 14. Revise § 524.1044f to read as
follows:
3. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
[Amended]
4. In paragraph (b) of § 520.1044a,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
I
§ 520.1195
[Amended]
5. In paragraph (b)(2) of § 520.1195,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
I
§ 520.1484
[Amended]
6. In paragraph (b)(1) of § 520.1484,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
I
§ 520.1485
[Amended]
7. In paragraph (b) of § 520.1485,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
I
§ 520.2220a
§ 524.1044f Gentamicin sulfate,
betamethasone valerate topical spray.
[Amended]
8. In paragraphs (a)(1) and (a)(2) of
§ 520.2220a, remove ‘‘051259’’ and add
in its place ‘‘054925’’.
I
§ 520.2345d
[Amended]
9. In paragraphs (b)(5), (d)(1)(iii), and
(d)(2)(iii) of § 520.2345d, remove
‘‘051259’’ and add in its place
‘‘054925’’.
HSROBINSON on PROD1PC70 with RULES
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
10. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
VerDate Aug<31>2005
§ 524.1193
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 520.1044a
I
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
*
14:40 Mar 15, 2006
Jkt 208001
[Amended]
15. In paragraph (b)(2) of § 524.1044g,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
11. In paragraph (b)(1) of § 522.900,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
Firm name and address
*
054925
§ 524.1044g
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
[Amended]
(a) Specifications. Each milliliter of
spray contains gentamicin sulfate
equivalent to 0.57 milligram (mg)
gentamicin base and betamethasone
valerate equivalent to 0.284 mg
betamethasone.
(b) Sponsors. See Nos. 000061 and
054925 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Hold bottle upright 3 to 6
inches from the lesion and depress the
sprayer head twice. Administer two
spray actuations two to four times daily
for 7 days.
(2) Indications for use. For the
treatment of infected superficial lesions
caused by bacteria sensitive to
gentamicin.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
[Amended]
16. In paragraph (b)(2) of § 524.1193,
remove ‘‘051259, 051311’’ and add in its
place ‘‘051311, 054925’’.
I 17. Revise § 524.1443 to read as
follows:
I
§ 524.1443
Miconazole.
(a) Specifications—(1) Each gram of
cream contains miconazole nitrate
equivalent to 20 milligrams miconazole
base.
(2) Each gram of lotion or spray
contains miconazole nitrate equivalent
to 1 percent miconazole base.
(b) Sponsors. See § 510.600(c) of this
chapter for use as in paragraph (c) of
this section:
(1) No. 000061 for use of cream,
lotion, and spray;
(2) Nos. 054925 and 058829 for use of
lotion and spray.
(c) Conditions of use in dogs and
cats—(1) Amount. Apply once daily by
rubbing into or spraying a light covering
on the infected site and the immediate
surrounding vicinity. Continue
treatment for 2 to 4 weeks until
infection is completely eradicated as
determined by appropriate laboratory
examination.
(2) Indications for use. For topical
treatment of infections caused by
Microsporum canis, Microsporum
gypseum, and Trichophyton
mentagrophytes.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 524.1580b
[Amended]
18. In paragraph (b)(1) of § 524.1580b,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
I
§ 524.1580e
[Amended]
19. In paragraph (b) of § 524.1580e,
remove ‘‘051259’’ and add in its place
‘‘054925’’.
I
§ 524.1600a
[Amended]
20. In paragraph (b) of § 524.1600a,
remove both occurrences of ‘‘051259,
and 053501’’ and add in their places
‘‘053501, and 054925’’.
I 21. Revise § 524.2481 to read as
follows:
I
§ 524.2481
Triamcinolone cream.
(a) Specifications. The vanishing
cream contains 0.1 percent
triamcinolone acetonide.
(b) Sponsor. See Nos. 053501 and
054925 in § 510.600(c) of this chapter.
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Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Rules and Regulations
(c) Conditions of use in dogs—(1)
Amount. Rub into affected areas two to
four times daily for 4 to 10 days.
(2) Indications for use. As an antiinflammatory, antipruritic, and
antiallergic agent for topical treatment
of allergic dermatitis and summer
eczema.
(3) Limitations. Federal law restricts
this drug to use only by or on the order
of a licensed veterinarian.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
22. The authority citation for 21 CFR
part 529 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 529.1044b
[Amended]
23. In paragraph (b) of § 529.1044b,
remove ‘‘Sponsor. See Nos. 000061 and
051259’’ and add in its place ‘‘Sponsors.
See Nos. 000061 and 054925’’.
I
Dated: March 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–2554 Filed 3–15–06; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[FRL–8022–1]
Approval and Promulgation of Air
Quality Implementation Plans;
Arkansas Update to Materials
Incorporated by Reference
Environmental Protection
Agency (EPA).
ACTION: Final rule; Notice of
administrative change.
HSROBINSON on PROD1PC70 with RULES
AGENCY:
SUMMARY: EPA is updating the materials
submitted by the State of Arkansas that
are incorporated by reference (IBR) into
the State Implementation Plan (SIP).
The regulations affected by this update
have been previously submitted by
Arkansas and approved by EPA. This
update affects the SIP materials that are
available for public inspection at the
National Archives and Records
Administration (NARA), the Air and
Radiation Docket and Information
Center located at EPA Headquarters in
Washington, DC, and the EPA Regional
Office.
DATES: This rule is effective on March
16, 2006.
ADDRESSES: SIP materials incorporated
by reference into 40 CFR part 52 are
available for inspection at the following
VerDate Aug<31>2005
14:40 Mar 15, 2006
Jkt 208001
locations: Environmental Protection
Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202–2733;
the EPA, Air and Radiation Docket and
Information Center, Air Docket (Mail
Code 6102T), 1200 Pennsylvania
Avenue, NW., Washington, DC 20460,
and the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
FOR FURTHER INFORMATION CONTACT: Carl
Young, Air Planning Section (6PD–L),
Environmental Protection Agency,
Region 6, 1445 Ross Avenue, Suite 700,
Dallas, Texas 75202–2733, telephone
214–665–6645; fax number 214–665–
7263, e-mail address
young.carl@epa.gov.
SUPPLEMENTARY INFORMATION: Each State
has an extensive SIP containing the
control measures and strategies—such
as air pollution control regulations,
emission inventories, monitoring
networks, attainment demonstrations,
and enforcement mechanisms—used to
attain and maintain the national
ambient air quality standards (NAAQS).
Each State must formally adopt the
control measures and strategies after the
public has had an opportunity to
comment on them and then must submit
them to EPA for approval. Once these
control measures and strategies are
approved by EPA, after notice and
comment, they are incorporated into the
federally approved SIP and are
identified in part 52, ‘‘Approval and
Promulgation of Implementation Plans’’,
Title 40 of the Code of Federal
Regulations (40 CFR part 52). The full
texts of a State’s control measures and
strategies approved by EPA are not
reproduced in their entirety in 40 CFR
part 52, but are ‘‘incorporated by
reference.’’ This means that EPA has
approved the identified State control
measures and strategies, each with a
specific effective date. The public is
referred to the locations of the full text
versions should they want to know
which measures are contained in a
given SIP. The information provided in
40 CFR part 52 allows EPA and the
public to monitor a State’s progress in
implementing its SIP (and thus in
attaining and maintaining the NAAQS)
and to take enforcement action if
necessary.
The SIP is a living document that the
State can revise as necessary to address
the unique air pollution problems in the
State. Therefore, to incorporate the
State’s revisions into the federally
PO 00000
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13543
approved SIP, EPA from time to time
must take action on SIP revisions
containing new and/or revised
measures. On May 22, 1997. (62 FR
27968), EPA revised the procedures for
incorporating by reference federally
approved SIPs into the Code of Federal
Regulations. These procedural revisions
changed the format for the identification
of a SIP in 40 CFR part 52, revised the
mechanisms for announcing EPA
approval of revisions to an applicable
SIP, and revised the mechanisms for
EPA’s updating of both the IBR
document (or SIP compilation) and the
CFR. The SIP compilations contain the
full text of the federally approved
materials (including regulations, sourcespecific permits, and nonregulatory
provisions and quasi-regulatory
measures) submitted by each State
agency, whereas the ‘‘Identification of
plan’’ sections in 40 CFR part 52 merely
identify the submitted materials
incorporated by reference into the
applicable SIP. Under the revised IBR
procedures, EPA periodically publishes
an informational document in the rules
section of the Federal Register when
updates are made to a State’s SIP
compilation. EPA’s 1997 revised IBR
procedures were formally applied to
Arkansas on October 23, 1998 (63 FR
56824).
This action notifies the public of an
update to the Arkansas SIP compilation,
available for public inspection at the
locations listed in the ADDRESSES
section of this Federal Register notice,
and updates the Arkansas
‘‘Identification of plan’’ section,
appearing in 40 CFR part 52 (subpart E).
The Arkansas SIP compilation, which
consists of submitted materials
incorporated by reference into the
Arkansas SIP, is being updated to
include EPA-approved revisions to
Arkansas’ SIP that have occurred since
EPA’s revised IBR procedures were
applied to Arkansas on October 23, 1998
(63 FR 56824); specifically, the SIP
compilation update includes revisions
to Arkansas Regulation 19, Regulations
of the Arkansas Plan of Implementation
for Air Pollution Control, which we
approved on October 16, 2000 (65 FR
61103), and revisions to Arkansas
Regulation 26, Regulations of the
Arkansas Operating Permit Program,
which we approved on October 9, 2001
(66 FR 51312). These revisions have
previously undergone notice and
comment rulemaking and are, therefore,
already in effect as a matter of law; thus
this SIP compilation update does not
affect the substance of those rulemaking
actions nor does it change the rights or
obligations of any party.
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]]>Agencies
[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Rules and Regulations]
[Pages 13541-13543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2554]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 529
New Animal Drugs; Change of Sponsor's Drug Labeler Code
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of drug labeler code for Med-
Pharmex, Inc.
DATES: This rule is effective March 16, 2006.
FOR FURTHER INFORMATION CONTACT: Charles Eastin, Center for Veterinary
Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9077, e-mail: charles.eastin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has found that the animal drug
regulations do not reflect the correct drug labeler code for Med-
Pharmex, Inc. Accordingly, the agency is amending the regulations in 21
CFR 510.600, 520.1044a, 520.1195, 520.1484, 520.1485, 520.2220a,
520.2345d, 522.900, 524.1044b, 524.1044f, 524.1044g, 524.1193,
524.1443, 524.1580b, 524.1580e, 524.1600a, 524.2481, and 529.1044b to
correct this error. In addition, 21 CFR 524.1044b, 524.1044f, 524.1443,
and 524.2481 are being revised to reflect a current format.
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 Parts 520, 522, 524, and 529
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,
520, 522, 524, and 529 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. Amend Sec. 510.600 in the table in paragraph (c)(1) in the entry
for ``Med-Pharmex, Inc.'' by removing ``051259'' and by adding in its
place ``054925''; and in the table in paragraph (c)(2) by removing the
entry for ``051259'' and by
[[Page 13542]]
numerically adding a new entry for ``054925'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
054925 Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767-1861
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1044a [Amended]
0
4. In paragraph (b) of Sec. 520.1044a, remove ``051259'' and add in
its place ``054925''.
Sec. 520.1195 [Amended]
0
5. In paragraph (b)(2) of Sec. 520.1195, remove ``051259'' and add in
its place ``054925''.
Sec. 520.1484 [Amended]
0
6. In paragraph (b)(1) of Sec. 520.1484, remove ``051259'' and add in
its place ``054925''.
Sec. 520.1485 [Amended]
0
7. In paragraph (b) of Sec. 520.1485, remove ``051259'' and add in its
place ``054925''.
Sec. 520.2220a [Amended]
0
8. In paragraphs (a)(1) and (a)(2) of Sec. 520.2220a, remove
``051259'' and add in its place ``054925''.
Sec. 520.2345d [Amended]
0
9. In paragraphs (b)(5), (d)(1)(iii), and (d)(2)(iii) of Sec.
520.2345d, remove ``051259'' and add in its place ``054925''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.900 [Amended]
0
11. In paragraph (b)(1) of Sec. 522.900, remove ``051259'' and add in
its place ``054925''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
12. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
13. Revise Sec. 524.1044b to read as follows:
Sec. 524.1044b Gentamicin sulfate, betamethasone valerate otic
solution.
(a) Specifications. Each milliliter of solution contains gentamicin
sulfate equivalent to 3 milligrams (mg) gentamicin base and
betamethasone valerate equivalent to 1 mg betamethasone alcohol.
(b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use--(1) Amounts and indications for use--(i) For
the treatment of acute and chronic otitis externa caused by bacteria
sensitive to gentamicin in dogs, instill three to eight drops of
solution into the ear canal twice daily for 7 to 14 days.
(ii) For the treatment of infected superficial lesions caused by
bacteria sensitive to gentamicin in dogs and cats, apply a sufficient
amount of the drug to cover the treatment area twice daily for 7 to 14
days.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
14. Revise Sec. 524.1044f to read as follows:
Sec. 524.1044f Gentamicin sulfate, betamethasone valerate topical
spray.
(a) Specifications. Each milliliter of spray contains gentamicin
sulfate equivalent to 0.57 milligram (mg) gentamicin base and
betamethasone valerate equivalent to 0.284 mg betamethasone.
(b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in dogs--(1) Amount. Hold bottle upright 3 to
6 inches from the lesion and depress the sprayer head twice. Administer
two spray actuations two to four times daily for 7 days.
(2) Indications for use. For the treatment of infected superficial
lesions caused by bacteria sensitive to gentamicin.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 524.1044g [Amended]
0
15. In paragraph (b)(2) of Sec. 524.1044g, remove ``051259'' and add
in its place ``054925''.
Sec. 524.1193 [Amended]
0
16. In paragraph (b)(2) of Sec. 524.1193, remove ``051259, 051311''
and add in its place ``051311, 054925''.
0
17. Revise Sec. 524.1443 to read as follows:
Sec. 524.1443 Miconazole.
(a) Specifications--(1) Each gram of cream contains miconazole
nitrate equivalent to 20 milligrams miconazole base.
(2) Each gram of lotion or spray contains miconazole nitrate
equivalent to 1 percent miconazole base.
(b) Sponsors. See Sec. 510.600(c) of this chapter for use as in
paragraph (c) of this section:
(1) No. 000061 for use of cream, lotion, and spray;
(2) Nos. 054925 and 058829 for use of lotion and spray.
(c) Conditions of use in dogs and cats--(1) Amount. Apply once
daily by rubbing into or spraying a light covering on the infected site
and the immediate surrounding vicinity. Continue treatment for 2 to 4
weeks until infection is completely eradicated as determined by
appropriate laboratory examination.
(2) Indications for use. For topical treatment of infections caused
by Microsporum canis, Microsporum gypseum, and Trichophyton
mentagrophytes.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 524.1580b [Amended]
0
18. In paragraph (b)(1) of Sec. 524.1580b, remove ``051259'' and add
in its place ``054925''.
Sec. 524.1580e [Amended]
0
19. In paragraph (b) of Sec. 524.1580e, remove ``051259'' and add in
its place ``054925''.
Sec. 524.1600a [Amended]
0
20. In paragraph (b) of Sec. 524.1600a, remove both occurrences of
``051259, and 053501'' and add in their places ``053501, and 054925''.
0
21. Revise Sec. 524.2481 to read as follows:
Sec. 524.2481 Triamcinolone cream.
(a) Specifications. The vanishing cream contains 0.1 percent
triamcinolone acetonide.
(b) Sponsor. See Nos. 053501 and 054925 in Sec. 510.600(c) of this
chapter.
[[Page 13543]]
(c) Conditions of use in dogs--(1) Amount. Rub into affected areas
two to four times daily for 4 to 10 days.
(2) Indications for use. As an anti-inflammatory, antipruritic, and
antiallergic agent for topical treatment of allergic dermatitis and
summer eczema.
(3) Limitations. Federal law restricts this drug to use only by or
on the order of a licensed veterinarian.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
22. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1044b [Amended]
0
23. In paragraph (b) of Sec. 529.1044b, remove ``Sponsor. See Nos.
000061 and 051259'' and add in its place ``Sponsors. See Nos. 000061
and 054925''.
Dated: March 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-2554 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-S
