Oral Dosage Form New Animal Drugs; Florfenicol, 262 [E6-22516]
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262
Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
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 520
Animal drugs.
I 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 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 520.455, revise the section
heading and paragraph (a) to read as
follows:
I
§ 520.455
Clomipramine tablets.
(a) Specifications. Each tablet
contains 5, 20, 40, or 80 milligrams (mg)
clomipramine hydrochloride.
*
*
*
*
*
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–22509 Filed 1–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
used in swine drinking water for the
treatment of respiratory disease.
DATES:
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit NJ 07901, filed a
supplement to NADA 141–206 for
NUFLOR (florfenicol) 2.3% Concentrate
Solution used to make medicated
drinking water for administration to
swine for the treatment of respiratory
disease associated with several bacterial
pathogens. The supplemental NADA
revises the nomenclature for a
respiratory pathogen in the label claim.
The supplemental NADA is approved as
of December 8, 2006, and the
regulations in 21 CFR 520.955 are
amended to reflect the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 520
Food and Drug Administration
Animal drugs.
21 CFR Part 520
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Schering-Plough Animal Health Corp.
The supplemental NADA revises the
nomenclature for a respiratory pathogen
in the label claim for florfenicol when
pwalker on PROD1PC65 with RULES
SUMMARY:
VerDate Aug<31>2005
00:35 Jan 04, 2007
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 520 is amended as follows:
I
Oral Dosage Form New Animal Drugs;
Florfenicol
AGENCY:
This rule is effective January 4,
2007.
Jkt 211001
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 520.955
[Amended]
2. In paragraph (d)(2) of § 520.955,
remove the words ‘‘Type 2’’.
I
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Dated: December 21, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–22516 Filed 12–29–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Dirlotapide
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 a new animal drug
application (NADA) filed by Pfizer, Inc.
The NADA provides for the veterinary
prescription use of dirlotapide solution
in dogs for the management of obesity.
DATES: This rule is effective January 4,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pfizer,
Inc., 235 East 42d St., New York, NY
10017–5755, filed NADA 141–260 for
SLENTROL (dirlotapide) Oral Solution.
The NADA provides for the veterinary
prescription use of dirlotapide solution
in dogs for the management of obesity.
The application is approved as of
December 12, 2006, and the regulations
are amended in 21 CFR part 520 by
adding new § 520.666 to reflect the
approval. The basis of approval is
discussed in the freedom of information
summary.
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.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
E:\FR\FM\04JAR1.SGM
04JAR1
Agencies
[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Page 262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Florfenicol
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 a supplemental new animal drug
application (NADA) filed by Schering-Plough Animal Health Corp. The
supplemental NADA revises the nomenclature for a respiratory pathogen
in the label claim for florfenicol when used in swine drinking water
for the treatment of respiratory disease.
DATES: This rule is effective January 4, 2007.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit NJ 07901, filed a supplement to NADA 141-206 for
NUFLOR (florfenicol) 2.3% Concentrate Solution used to make medicated
drinking water for administration to swine for the treatment of
respiratory disease associated with several bacterial pathogens. The
supplemental NADA revises the nomenclature for a respiratory pathogen
in the label claim. The supplemental NADA is approved as of December 8,
2006, and the regulations in 21 CFR 520.955 are amended to reflect the
approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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 in 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 part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.955 [Amended]
0
2. In paragraph (d)(2) of Sec. 520.955, remove the words ``Type 2''.
Dated: December 21, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-22516 Filed 12-29-06; 8:45 am]
BILLING CODE 4160-01-S