[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Rules and Regulations]
[Pages 22610-22611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9765]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2011-N-0003]
Implantation or Injectable Dosage Form New Animal Drugs;
Enrofloxacin
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 Bayer HealthCare LLC. The supplemental NADA
provides for the addition of a pathogen to the indications for use of
enrofloxacin solution in cattle, as a single injection, for the
treatment of respiratory disease.
DATES: This rule is effective April 22, 2011.
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: Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement
to NADA 141-068 for BAYTRIL 100 (enrofloxacin), an injectable solution.
The supplemental NADA provides for the addition of Mycoplasma bovis to
the pathogens in the indication for use of enrofloxacin solution in
cattle, as a single injection, for the treatment of bovine respiratory
disease (BRD). The supplemental NADA is approved as of March 10, 2011,
and the regulation in 21 CFR 522.812 is amended to reflect the
approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and Sec. 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
[[Page 22611]]
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
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. 522.812, revise paragraph (e)(2)(ii) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(e) * * *
(2) * * *
(ii) Indications for use--(A) Single-dose therapy: For the
treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and
Mycoplasma bovis in beef and non-lactating dairy cattle.
(B) Multiple-day therapy: For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni in beef and non-lactating dairy
cattle.
* * * * *
Dated: April 15, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-9765 Filed 4-21-11; 8:45 am]
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