New Animal Drugs; Change of Sponsor's Address, 27955 [E7-9555]
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Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Rules and Regulations
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Issued in Kansas City, Missouri, on May 9,
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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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[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Rules and Regulations]
[Page 27955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9555]
=======================================================================
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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.
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, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Modern Veterinary Therapeutics, LLC, 18301
SW. 86th Ave., Miami, FL 33157, has 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.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 part 510 is
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) revise the entry
for ``Modern Veterinary Therapeutics, LLC''; and in the table in
paragraph (c)(2) revise the entry for ``015914'' 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
------------------------------------------------------------------------
* * * * *
Modern Veterinary Therapeutics, LLC, 1550 Madruga Ave., 015914
suite 329, Coral Gables, FL 33146......................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
015914 Modern Veterinary Therapeutics, LLC, 1550
Madruga Ave., suite 329, Coral Gables, FL
33146
* * * * *
------------------------------------------------------------------------
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9555 Filed 5-17-07; 8:45 am]
BILLING CODE 4160-01-S
