[Federal Register Volume 61, Number 190 (Monday, September 30, 1996)]
[Rules and Regulations]
[Page 51003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; 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 a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health, Division of Eli Lilly 
and Co. The supplemental NADA provides for monensin Type A medicated 
articles to be used to make free-choice Type C medicated feeds for 
pasture cattle weighing less than 400 pounds for increased rate of 
weight gain.

EFFECTIVE DATE: September 30, 1996.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, Division of Eli Lilly 
and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
supplemental NADA 95-735, which provides for use of a monensin Type A 
medicated article to make a monensin Type C medicated feed/free-choice 
mineral granule containing 1620 grams monensin per ton (g/t) to be fed 
at 50 to 200 milligrams per head per day free-choice to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers) 
for increased rate of weight gain.
    The supplemental NADA provides for removal of the restriction 
concerning use of the product for animals weighing less than 400 pounds 
body weight. The supplemental NADA is approved as of September 30, 
1996, and the regulations are amended in 21 CFR 558.355(f)(3)(x)(c) to 
reflect the approval.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), approval of this 
supplemental NADA does not qualify for marketing exclusivity because 
the supplement does not contain reports of new clinical or field 
investigations (other than bioequivalence or residue studies) or new 
human food safety studies (other than bioequivalence or residue 
studies) essential to the approval and conducted or sponsored by the 
applicant.
    Approval of this supplemental NADA does not require a freedom of 
information (FOI) summary because the approval relies on data and 
information filed to support a previously approved supplement. FOI 
summaries for prior approvals may be seen in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857, from 9 a.m. to 4 p.m., Monday through 
Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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 558

    Animal drugs, Animal feeds
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.355  [Amended]

    2. Section 558.355 Monensin is amended in paragraph (f)(3)(x)(c) in 
the first sentence by removing the phrase ``weighing more than 400 
pounds''.

    Dated: September 3, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-24965 Filed 9-27-96; 8:45 am]
BILLING CODE 4160-01-F