[Federal Register Volume 62, Number 25 (Thursday, February 6, 1997)]
[Rules and Regulations]
[Page 5526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Tilmicosin Phosphate Injection

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 and Co. The supplemental NADA provides for subcutaneous use of 
tilmicosin phosphate injection for the control of respiratory disease 
in cattle at high risk of developing bovine respiratory disease (BRD) 
associated with Pasteurella haemolytica.

EFFECTIVE DATE: February 6, 1997.
FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1659.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, a Division of Eli 
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, is 
sponsor of NADA 140-929, which provides for the subcutaneous use of 
Micotil 300 (tilmicosin phosphate) Injection for the 
treatment of cattle with bovine respiratory disease (BRD) associated 
with P. haemolytica. The drug is limited to use by or on the order of a 
licensed veterinarian. The firm filed a supplemental NADA, which 
provides for use of Micotil for the control of respiratory 
disease in cattle at high risk of developing BRD associated with P. 
haemolytica. The supplement is approved as of December 30, 1996, and 21 
CFR 522.2471(d)(1)(ii) is amended to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    Also, certain limitation statements for use of the product are 
revised to reflect current wording. Section 522.2471(d)(1)(iii) is 
amended by revising two sentences.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
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 approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning December 30, 1996, because the supplemental application 
contains substantial evidence of the effectiveness of the drug 
involved, any studies of animal safety, or, in the case of food 
producing animals, human food safety studies (other than bioequivalence 
or residue studies) required for approval of the supplement and 
conducted or sponsored by the applicant. The 3 years of marketing 
exclusivity applies only to the new claim, control of respiratory 
disease in cattle at high risk of developing BRD associated with P. 
haemolytica, for which the the supplemental application was approved.
     The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that this action will not 
have a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

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

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2.Section 522.2471 is amended by revising paragraph (d)(1)(ii) and 
the last four sentences of paragraph (d)(1)(iii) to read as follows:


Sec. 522.2471  Tilmicosin phosphate injection.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Pasteurella haemolytica. For the control 
of respiratory disease in cattle at high risk of developing BRD 
associated with P. haemolytica.
    (iii) * * * A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal. Do not slaughter within 28 days of last treatment. Federal 
law restricts this drug to use or on the order of a licensed 
veterinarian.
* * * * *

    Dated: January 27, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation Center for Veterinary 
Medicine
[FR Doc. 97-3016 Filed 2-5-97; 8:45 am]
BILLING CODE 4160-01-F