Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid, 4692 [2010-1790]
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Federal Register / Vol. 75, No. 19 / Friday, January 29, 2010 / Rules and Regulations
ensure that the parties to proceedings
are known to each other and to the
Commission and that service of
pleadings and orders is provided to all
parties.
17. Moreover, to permit the easy
identification of related filings for
compliance filings receiving new root
dockets,19 pipelines and utilities are
urged to include as part of their eFiling
description an indication that they are
making a compliance filing and the
docket number to which they are
complying. This filing description will
appear in the Commission’s notice and
will aid in the identification of the
relationship between the compliance
filing and the original proceeding.
The Commission Orders
(A) The procedures described in the
body of this order will apply to tariff
filings that are submitted in electronic
format.
(B) The Secretary shall publish a copy
of this order in the Federal Register.
By the Commission. Commissioner Norris
voting present.
Kimberly D. Bose,
Secretary.
[FR Doc. 2010–1538 Filed 1–28–10; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2010–N–0002]
Implantation or Injectable Dosage
Form New Animal Drugs; Ceftiofur
Crystalline Free Acid
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on DSK2BSOYB1PROD with RULES
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
Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA
provides for veterinarian prescription
use of ceftiofur crystalline free acid
injectable suspension for the treatment
of lower respiratory tract infections in
horses.
DATES: This rule is effective January 29,
2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
19 These will be filings without the Filing
Identifier of a related filing.
VerDate Nov<24>2008
14:42 Jan 28, 2010
Jkt 220001
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed a supplement to NADA 141–209
for EXCEDE (ceftiofur crystalline free
acid) Sterile Suspension. The
supplemental NADA provides for
veterinarian prescription use of ceftiofur
crystalline free acid injectable
suspension for the treatment of lower
respiratory tract infections in horses
caused by susceptible strains of
Streptococcus equi ssp. zooepidemicus.
The application is approved as of
December 16, 2009, and the regulations
are amended in 21 CFR 522.313a to
reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii),
summaries of the safety and
effectiveness data and information
submitted to support approval of these
applications 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)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval.
The agency 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 522
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 part 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
Authority: 21 U.S.C. 360b.
2. In § 522.313a, add paragraph (e)(3)
to read as follows:
■
§ 522.313a
Ceftiofur crystalline free acid.
*
*
*
*
*
(e) * * *
(3) Horses—(i) Amount. Two
intramuscular injections, 4 days apart,
at a dose of 3.0 mg/lb (6.6 mg/kg) body
weight.
(ii) Indications for use. For the
treatment of lower respiratory tract
infections in horses caused by
susceptible strains of Streptococcus equi
ssp. zooepidemicus.
(iii) Limitations. Do not use in horses
intended for human consumption.
Dated: January 22, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–1790 Filed 1–28–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA–2010–N–0002]
Ophthalmic and Topical Dosage Form
New Animal Drugs; Miconazole,
Polymixin B, and Prednisolone
Suspension
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 Janssen
Pharmaceutica NV. The NADA provides
for use of miconazole nitrate, polymixin
B sulfate, and prednisolone acetate for
the treatment of otitis externa in dogs.
DATES: This rule is effective January 29,
2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Janssen
Pharmaceutica NV, Turnhoutseweg 30,
B–2340 Beerse, Belgium, filed NADA
141–298 that provides for veterinary
prescription use of SUROLAN
(miconazole nitrate, polymixin B
sulfate, and prednisolone acetate) Otic
Suspension in dogs for the treatment of
otitis externa associated with
E:\FR\FM\29JAR1.SGM
29JAR1
]]>Agencies
[Federal Register Volume 75, Number 19 (Friday, January 29, 2010)]
[Rules and Regulations]
[Page 4692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2010-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs;
Ceftiofur Crystalline Free Acid
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 Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA provides for veterinarian
prescription use of ceftiofur crystalline free acid injectable
suspension for the treatment of lower respiratory tract infections in
horses.
DATES: This rule is effective January 29, 2010.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement
to NADA 141-209 for EXCEDE (ceftiofur crystalline free acid) Sterile
Suspension. The supplemental NADA provides for veterinarian
prescription use of ceftiofur crystalline free acid injectable
suspension for the treatment of lower respiratory tract infections in
horses caused by susceptible strains of Streptococcus equi ssp.
zooepidemicus. The application is approved as of December 16, 2009, and
the regulations are amended in 21 CFR 522.313a to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and
effectiveness data and information submitted to support approval of
these applications 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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
The agency 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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.313a, add paragraph (e)(3) to read as follows:
Sec. 522.313a Ceftiofur crystalline free acid.
* * * * *
(e) * * *
(3) Horses--(i) Amount. Two intramuscular injections, 4 days apart,
at a dose of 3.0 mg/lb (6.6 mg/kg) body weight.
(ii) Indications for use. For the treatment of lower respiratory
tract infections in horses caused by susceptible strains of
Streptococcus equi ssp. zooepidemicus.
(iii) Limitations. Do not use in horses intended for human
consumption.
Dated: January 22, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-1790 Filed 1-28-10; 8:45 am]
BILLING CODE 4160-01-S
