Document ID: FDA-2008-N-0039-0075
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid
Posted Date: 2008-10-08T04:00Z

[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]               
[Page 58871-58872]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc08-3]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2008-N-0039]

 
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

[[Page 58872]]

of bovine foot rot (interdigital necrobacillosis).

DATES:  This rule is effective October 8, 2008.

FOR FURTHER INFORMATION CONTACT:  Donald A. Prater, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: 
donald.prater@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 bovine foot rot (interdigital 
necrobacillosis) in beef, non-lactating dairy, and lactating dairy 
cattle. The application is approved as of August 15, 2008, 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 3 years of marketing exclusivity apply only to the bovine 
foot rot indication for which this supplement is approved.
    The agency has determined under 21 CFR 25.33(d)(5) 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, amend paragraph (e)(2)(ii) by adding a third 
sentence to read as follows:

Sec.  522.313a   Ceftiofur crystalline free acid.

* * * * *
    (e) * * *
    (2) * * *
    (ii) * * * For the treatment of bovine foot rot (interdigital 
necrobacillosis) associated with Fusobacterium necrophorum and 
Porphyromonas levii in beef, non-lactating dairy, and lactating dairy 
cattle.
* * * * *

    Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-23830 Filed 10-7-08; 8:45 am]

BILLING CODE 4160-01-S