[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