Document ID: FDA-2009-N-0665-0072
Agency: fda
Document Type: Notice
Title: Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol
Posted Date: 2009-12-16T05:00Z

[Federal Register: December 16, 2009 (Volume 74, Number 240)]
[Rules and Regulations]               
[Page 66573-66574]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de09-9]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Florfenicol

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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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 Intervet, Inc. The supplemental NADA adds 
Mycoplasma bovis to the bovine respiratory disease pathogens for which 
florfenicol injectable solution is approved as a treatment.

DATES: This rule is effective December 16, 2009.

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: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068, filed a supplement to NADA 141-265 that provides 
for use of NUFLOR GOLD (florfenicol) Injectable Solution for treatment 
of bovine respiratory disease in beef and non-lactating dairy cattle. 
The supplement adds Mycoplasma bovis to the list of pathogens for which 
use of this product is approved. The supplemental NADA is approved as 
of September 4, 2009, and the regulations are amended in 21 CFR 522.955 
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), 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 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

[[Page 66574]]

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.  522.955, revise paragraph (d)(1)(i)(B) and in paragraph 
(d)(1)(i)(C), in the first sentence, remove ``last'' to read as 
follows:

Sec.  522.955  Florfenicol.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (B) Indications for use. For treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, Histophilus somni, and Mycoplasma bovis in beef and non-
lactating dairy cattle.
* * * * *

    Dated: December 10, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29875 Filed 12-15-09; 8:45 am]

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