[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Rules and Regulations]
[Pages 54018-54019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22039]
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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;
Florfenicol and Flunixin
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 (BRD) pathogens for
which use of an injectable solution containing florfenicol and flunixin
meglumine is an approved treatment.
DATES: This rule is effective September 3, 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:
[email protected].
SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068, filed a supplement to NADA 141-299 that provides
for use of RESFLOR GOLD (florfenicol and flunixin meglumine), a
combination drug injectable solution. The supplement adds M. bovis to
the BRD pathogens for which the use of this product is approved. The
supplemental NADA is approved as of June 7, 2010, and the regulations
in 21 CFR 522.956 are amended 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 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.
[[Page 54019]]
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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
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1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 522.956, revise paragraph (d)(2) to read as follows:
Sec. 522.956 Florfenicol and flunixin.
* * * * *
(d) * * *
(2) Indications for use. For treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-
associated pyrexia in beef and non-lactating dairy cattle.
* * * * *
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22039 Filed 9-2-10; 8:45 am]
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