Document ID: FDA-2010-N-0002-0069
Agency: fda
Document Type: Rule
Title: Implantation and Injectable Dosage Form New Animal Drugs: Ceftiofur Crystalline Free Acid; Technical Amendment
Posted Date: 2010-10-12T04:00Z

[Federal Register: October 12, 2010 (Volume 75, Number 196)]
[Rules and Regulations]               
[Page 62468]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12oc10-9]                         

[[Page 62468]]

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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 and Injectable Dosage Form New Animal Drugs; 
Ceftiofur Crystalline Free Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 veterinary prescription 
use of ceftiofur crystalline free acid suspension in swine, by 
intramuscular injection, for the control of swine respiratory disease 
(SRD) in groups of pigs where SRD has been diagnosed.

DATES: This rule is effective October 12, 2010.

FOR FURTHER INFORMATION CONTACT:  Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@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 141 235 for EXCEDE (ceftiofur crystalline free acid) for Swine 
Sterile Suspension. The supplemental NADA provides for the veterinary 
prescription use of ceftiofur crystalline free acid suspension in 
swine, by intramuscular injection, for the control of SRD associated 
with Actinobacillus pleuropneumoniae, Pasteurella multocida, 
Haemophilus parasuis, and Streptococcus suis in groups of pigs where 
SRD has been diagnosed. The application is approved as of September 15, 
2010, and the regulations are amended in 21 CFR 522.313a to reflect the 
approval. In addition, the regulations are amended to specify which 
strength of two approved formulations is approved for use in horses. 
This is being done to improve the accuracy of the 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.
    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 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 a second sentence to paragraph (e)(1)(ii) and 
revise paragraph (e)(3) to read as follows:

Sec.  522.313a  Ceftiofur crystalline free acid.

* * * * *
    (e) * * *
    (1) * * *
    (ii) * * * For the control of SRD associated with A. 
pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of 
pigs where SRD has been diagnosed.
* * * * *
    (3) Horses. The formulation described in paragraph (a)(2) of this 
section is used as follows:
    (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: October 5, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-25527 Filed 10-8-10; 8:45 am]
BILLING CODE 4160-01-P