[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Rules and Regulations]
[Page 6862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3355]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Monensin

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 two supplemental new animal 
drug applications (NADA's) filed by Elanco Animal Health, Division of 
Eli Lilly & Co. The supplemental NADA's provide for transferring the 
data and information in one NADA into another and withdrawing approval 
of the vacated NADA. The NADA's provide for use of monensin Type A 
medicated articles to make a free-choice Type C medicated feed/mineral 
granules for pastured cattle for increased rate of weight gain.

EFFECTIVE DATE: February 23, 1998.

FOR FURTHER INFORMATION CONTACT: Russell G. Arnold, Center for 
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1674.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, Division of Eli Lilly 
& Co., Lilly Corporate Center, Indianapolis, IN 46285, is the sponsor 
of NADA's 95-735 and 119-823, both of which provide for use of a 
monensin Type A medicated article to make a monensin Type C medicated 
feed/free-choice mineral granules containing 810 milligrams monensin 
per pound (1,620 grams monensin per ton) to be fed free-choice to 
pasture cattle (slaughter, stocker, feeder, and dairy and beef 
replacement heifers) for increased rate of weight gain (see 21 CFR 
520.1448b and 558.355(f)(3)(x)).
    Elanco Animal Health, Division of Eli Lilly & Co. filed 
supplemental NADA's that provide for combining data and information in 
NADA 119-823 into NADA 95-735 and withdrawing approval of NADA 119-823. 
Supplemental NADA 95-735 is approved as of November 3, 1997, and the 
regulations are amended in part 520 (21 CFR part 520) by removing 
Sec. 520.1448b to reflect the approval.
    Approval of the supplemental NADA 95-735 or withdrawal of approval 
of NADA 119-823 does not require a freedom of information summary 
because the actions concern a change in status of existing applications 
and do not change the conditions of use of the products. This change 
does not affect the product's safety or effectiveness.
    The agency has determined under 21 CFR 25.33(a)(1) and (g) that 
these actions are of a type that do 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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec. 520.1448b  [Removed]

    2. Section 520.1448b Monensin-mineral granules is removed.

    Dated: January 22, 1998.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-3355 Filed 2-10-98; 8:45 am]
BILLING CODE 4160-01-F