[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
