[Federal Register Volume 63, Number 31 (Tuesday, February 17, 1998)]
[Rules and Regulations]
[Page 7701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3897]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 removal of the label
warnings concerning subcutaneous use of tilmicosin phosphate injection
in preruminating (veal) calves. Removal of the warning is based on a
tissue residue depletion study in calves less than 1 month of age.
EFFECTIVE DATE: February 17, 1998.
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 that provides for the subcutaneous use of
Micotil 300 (tilmicosin phosphate) Injection for the
treatment of cattle with bovine respiratory disease (BRD) associated
with Pasteurella haemolytica. The drug is limited to use by or on the
order of a licensed veterinarian. The firm filed a supplemental NADA
providing for removal of the warning statements regarding use of the
product in preruminating (veal) calves. The supplemental NADA is
approved as of December 23, 1997, and the regulations are amended in 21
CFR 522.2471(d)(1)(iii) to reflect the approval. The basis of approval
is discussed in the freedom of information summary.
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.
The agency has determined under 21 CFR 25.33(a)(1) 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.
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
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.2471 [Amended]
2. Section 522.2471 Tilmicosin phosphate injection is amended in
paragraph (d)(1)(iii) by removing the 13th and 14th sentences.
Dated: January 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-3897 Filed 2-13-98; 8:45 am]
BILLING CODE 4160-01-F
