[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Rules and Regulations]
[Pages 9333-9334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4206]
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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;
Tilmicosin
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 Elanco Animal Health, A Division of Eli
Lilly & Co. The supplemental NADA provides a dose range for use of an
injectable solution of tilmicosin phosphate for treatment of
respiratory disease in cattle and additional pathogens for which this
therapy is effective.
DATES: This rule is effective March 2, 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: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 140-929 for MICOTIL 300 (tilmicosin injection, USP)
Injection, available by veterinary prescription for use in the
treatment and control of respiratory disease in cattle and the
treatment of respiratory disease in sheep. The supplemental NADA
establishes a dose range and adds pathogens for which this therapy is
effective in the management of bovine respiratory disease. As a
consequence of revising the dosage, the preslaughter withdrawal period
has been recalculated. The supplemental NADA is approved as of December
30, 2009, and the regulations in 21 CFR 522.2471 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
[[Page 9334]]
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
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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. 522.2471, revise paragraphs (e)(1)(i), (e)(1)(ii), and
(e)(1)(iii) to read as follows:
Sec. 522.2471 Tilmicosin.
* * * * *
(e) * * *
(1) * * *
(i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body
weight as a single subcutaneous injection.
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni. For the control of respiratory
disease in cattle at high risk of developing BRD associated with M.
haemolytica.
(iii) Limitations. Do not use in female dairy cattle 20 months of
age or older. Use of this antibiotic in this class of cattle may cause
milk residues. Do not slaughter within 42 days of last treatment.
* * * * *
Dated: February 16, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-4206 Filed 3-1-10; 8:45 am]
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