Oral Dosage Form New Animal Drugs; Phenylbutazone Powder, 27955-27956 [E7-9559]
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Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Rules and Regulations
Room 301, Kansas City, Missouri 64106;
telephone: (816) 329–4138; fax: (816) 329–
4090. Before using any approved AMOC on
any airplane to which the AMOC applies,
notify your appropriate principal inspector
(PI) in the FAA Flight Standards District
Office (FSDO), or lacking a PI, your local
FSDO.
(2) Airworthy Product: For any requirement
in this AD to obtain corrective actions from
a manufacturer or other source, use these
actions if they are FAA-approved. Corrective
actions are considered FAA-approved if they
are approved by the State of Design Authority
(or their delegated agent). You are required
to assure the product is airworthy before it
is returned to service.
(3) Reporting Requirements: For any
reporting requirement in this AD, under the
provisions of the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.), the Office of
Management and Budget (OMB) has
approved the information collection
requirements and has assigned OMB Control
Number 2120–0056.
Related Information
(h) Refer to MCAI Civil Aviation Authority
AD No. G–2004–0024, Issue Date: September
22, 2004, EASA approved on September 16,
2004, under approval number 2004–9648, for
related information.
Issued in Kansas City, Missouri, on May 9,
2007.
Charles L. Smalley,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 07–2472 Filed 5–17–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s address for Modern
Veterinary Therapeutics, LLC.
DATES: This rule is effective May 18,
2007.
cprice-sewell on PRODPC61 with RULES
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Modern
Veterinary Therapeutics, LLC, 18301
SW. 86th Ave., Miami, FL 33157, has
VerDate Aug<31>2005
15:21 May 17, 2007
Jkt 211001
27955
informed FDA of a change of address to
1550 Madruga Ave., suite 329, Coral
Gables, FL 33146. Accordingly, the
agency is amending the regulations in
21 CFR 510.600(c) to reflect the change.
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.
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–9555 Filed 5–17–07; 8:45 am]
List of Subjects in 21 CFR Part 510
21 CFR Parts 510 and 520
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
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 part 510 is amended as follows:
I
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oral Dosage Form New Animal Drugs;
Phenylbutazone Powder
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 an abbreviated new animal
drug application (ANADA) filed by
Superior Equine Pharmaceuticals, Inc.
PART 510—NEW ANIMAL DRUGS
The ANADA provides for the veterinary
prescription use of phenylbutazone
I 1. The authority citation for 21 CFR
powder administered to horses in feed
part 510 continues to read as follows:
for the relief of inflammatory conditions
Authority: 21 U.S.C. 321, 331, 351, 352,
associated with the musculoskeletal
353, 360b, 371, 379e.
system.
I 2. In § 510.600, in the table in
DATES: This rule is effective May 18,
paragraph (c)(1) revise the entry for
2007.
‘‘Modern Veterinary Therapeutics,
FOR FURTHER INFORMATION CONTACT: John
LLC’’; and in the table in paragraph
K. Harshman, Center for Veterinary
(c)(2) revise the entry for ‘‘015914’’ to
Medicine (HFV–104), Food and Drug
read as follows:
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, e§ 510.600 Names, addresses, and drug
mail: john.harshman@fda.hhs.gov.
labeler codes of sponsors of approved
SUPPLEMENTARY INFORMATION: Superior
applications.
Equine Pharmaceuticals, Inc., Pleasant
*
*
*
*
*
Grove, UT 84062, filed ANADA 200–
(c) * * *
333 that provides for the veterinary
prescription use of SUPERIORBUTE
(1) * * *
(phenylbutazone) Powder administered
to horses in feed for the relief of
Drug labeler
Firm name and address
code
inflammatory conditions associated
with the musculoskeletal system.
*
*
*
*
*
Superior Equine Pharmaceuticals, Inc.’s
Modern Veterinary TheraSUPERIORBUTE Powder is approved as
peutics, LLC, 1550
a generic copy of IVX Animal Health,
Madruga Ave., suite 329,
Inc.’s Phenylbutazone Tablets, USP,
Coral Gables, FL 33146
015914
approved under NADA 91–818. The
*
*
*
*
*
ANADA is approved as of April 20,
2007, and the regulations are amended
(2) * * *
in 21 CFR 520.1720e to reflect the
approval. The basis of approval is
Drug labeler
discussed in the freedom of information
Firm name and address
code
summary.
In addition, Superior Equine
*
*
*
*
*
Pharmaceuticals, Inc., has not been
015914
Modern Veterinary Therapreviously listed in the animal drug
peutics, LLC, 1550
regulations as a sponsor of an approved
Madruga Ave., suite 329,
application. At this time, 21 CFR
Coral Gables, FL 33146
510.600(c) is being amended to add
*
*
*
*
*
entries for the firm.
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27956
Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Rules and Regulations
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.
FDA has determined under 21 CFR
25.33 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.
Firm name and address
Drug labeler code
*
*
*
Superior Equine Pharmaceuticals, Inc.,
Pleasant Grove, UT
84062
*
*
*
*
*
Food and Drug Administration
027053
*
*
(2) * * *
Firm name and address
*
027053
*
*
*
*
*
*
Superior Equine Pharmaceuticals, Inc.,
Pleasant Grove, UT
84062.
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
(a) Specifications—(1) Each 1.15
grams (g) of powder contains 1 g
phenylbutazone.
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 520 are amended as
follows:
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. Section 510.600 is amended in the
table in paragraph (c)(1) by
alphabetically adding a new entry for
‘‘Superior Equine Pharmaceuticals,
Inc.’’ and in the table in paragraph (c)(2)
by numerically adding a new entry for
‘‘027053’’ to read as follows:
cprice-sewell on PRODPC61 with RULES
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
VerDate Aug<31>2005
*
*
Phenylbutazone powder.
(2) Each 10 g of powder contains 1 g
phenylbutazone.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter.
(1) No. 027053 for use of product
described in paragraph (a)(1) of this
section.
(2) No. 057699 for use of product
described in paragraph (a)(2) of this
section.
(c) Conditions of use in horses—(1)
Amount. Administer 1 to 2 g (1 to 2
level scoops, using the scoop provided)
per 500 pounds of body weight on a
small amount of palatable feed, not
exceed 4 g per animal daily.
(2) Indications for use. For the relief
of inflammatory conditions associated
with the musculosketetal system.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law prohibits the extralabel use
of this product in female cattle 20
months of age or older. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–9559 Filed 5–17–07; 8:45 am]
BILLING CODE 4160–01–S
15:21 May 17, 2007
Jkt 211001
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
Food and Drug Administration,
HHS.
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by IVX
Animal Health, Inc. The ANADA
provides for veterinary prescription use
of butorphanol tartrate injectable
solution in cats for the relief of pain.
DATES: This rule is effective May 18,
2007.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
ANADA 200–408 that provides for
veterinary prescription use of
Butorphanol Tartrate Injection (2mg/
mL) in cats for the relief of pain. IVX
Animal Health, Inc.’s Butorphanol
Tartrate Injection (2mg/mL) is approved
as a generic copy of Fort Dodge Animal
Health, a Div. of Wyeth’s
TORBUGESIC–SA (butorphanol tartrate,
USP), approved under NADA 141–047.
The ANADA is approved as of April 20,
2007, and the regulations are amended
in 21 CFR 522.246 to reflect the
approval and a current format.
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.
FDA 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.
FOR FURTHER INFORMATION CONTACT:
4. Revise § 520.1720e, to read as
follows:
I
§ 520.1720e
I
Implantation or Injectable Dosage
Form New Animal Drugs; Butorphanol
ACTION:
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Animal drugs.
21 CFR Part 522
AGENCY:
Drug labeler
code
List of Subjects in 21 CFR Part 510
21 CFR Part 520
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
E:\FR\FM\18MYR1.SGM
18MYR1
]]>Agencies
[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Rules and Regulations]
[Pages 27955-27956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9559]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Oral Dosage Form New Animal Drugs; Phenylbutazone Powder
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 an abbreviated new animal drug
application (ANADA) filed by Superior Equine Pharmaceuticals, Inc. The
ANADA provides for the veterinary prescription use of phenylbutazone
powder administered to horses in feed for the relief of inflammatory
conditions associated with the musculoskeletal system.
DATES: This rule is effective May 18, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Superior Equine Pharmaceuticals, Inc.,
Pleasant Grove, UT 84062, filed ANADA 200-333 that provides for the
veterinary prescription use of SUPERIORBUTE (phenylbutazone) Powder
administered to horses in feed for the relief of inflammatory
conditions associated with the musculoskeletal system. Superior Equine
Pharmaceuticals, Inc.'s SUPERIORBUTE Powder is approved as a generic
copy of IVX Animal Health, Inc.'s Phenylbutazone Tablets, USP, approved
under NADA 91-818. The ANADA is approved as of April 20, 2007, and the
regulations are amended in 21 CFR 520.1720e to reflect the approval.
The basis of approval is discussed in the freedom of information
summary.
In addition, Superior Equine Pharmaceuticals, Inc., has not been
previously listed in the animal drug regulations as a sponsor of an
approved application. At this time, 21 CFR 510.600(c) is being amended
to add entries for the firm.
[[Page 27956]]
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.
FDA has determined under 21 CFR 25.33 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 in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
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
520 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. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``Superior Equine
Pharmaceuticals, Inc.'' and in the table in paragraph (c)(2) by
numerically adding a new entry for ``027053'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Superior Equine Pharmaceuticals, Inc., Pleasant Grove, 027053
UT 84062
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
027053 Superior Equine Pharmaceuticals, Inc.,
Pleasant Grove, UT 84062.
* * * * *
------------------------------------------------------------------------
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.
0
4. Revise Sec. 520.1720e, to read as follows:
Sec. 520.1720e Phenylbutazone powder.
(a) Specifications--(1) Each 1.15 grams (g) of powder contains 1 g
phenylbutazone.
(2) Each 10 g of powder contains 1 g phenylbutazone.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 027053 for use of product described in paragraph (a)(1) of
this section.
(2) No. 057699 for use of product described in paragraph (a)(2) of
this section.
(c) Conditions of use in horses--(1) Amount. Administer 1 to 2 g (1
to 2 level scoops, using the scoop provided) per 500 pounds of body
weight on a small amount of palatable feed, not exceed 4 g per animal
daily.
(2) Indications for use. For the relief of inflammatory conditions
associated with the musculosketetal system.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law prohibits the extralabel use of this product
in female cattle 20 months of age or older. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9559 Filed 5-17-07; 8:45 am]
BILLING CODE 4160-01-S
