[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Pages 14305-14306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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

[[Page 14306]]

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 use of monensin Type A medicated articles to make a 
revised formulation of a free-choice Type C medicated feed for pastured 
cattle for increased rate of weight gain.

EFFECTIVE DATE: March 26, 1997.

ADDRESSES: Data and information filed to support previous approvals may 
be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
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 
and Co., Lilly Corporate Center, Indianapolis, IN 46285, is the sponsor 
of 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 1,620 grams monensin per ton 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.
    Elanco Animal Health, Division of Eli Lilly and Co. filed a 
supplemental NADA that provides for a revised formulation of the Type C 
medicated feed/free-choice granule to properly reflect the salt and 
mineral content of the product. The supplemental NADA is approved as of 
March 26, 1997, and the regulations are amended in 21 CFR 
558.355(f)(3)(x)(b) to reflect the approval.
    In addition, Sec. 558.355(f)(3)(x)(b) is amended in the table to 
correct some editorial and typographical errors in the entry for 
``Ground limestone (33% calcium)'' and in the entries for ``6-01-080'' 
and ``4-04-152,'' respectively.
    Approval of this supplement does not require a freedom of 
information summary because the approval concerns a change in salt and 
mineral content of the product. This change does not affect the 
product's safety or effectiveness. Therefore, no additional data was 
required for this approval. Data and information filed to support 
previous approvals may be seen in the Dockets Management Branch (HFA-
305) (address above) between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(iii) 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 
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 the table in paragraph 
(f)(3)(x)(b), in the first column, in the entry for ``Ground limestone 
(33% calcium)'' by adding the phrase ``or calcium carbonate (38% 
calcium)'' and in the third column in the first and third entries by 
removing the numbers ``6-01-080'' and ``4-04-152'' and adding in their 
place the numbers ``6-01-082'' and ``4-04-695'', respectively.

    Dated: March 13, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-7551 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F