[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
