[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Pages 14303-14304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7546]


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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 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 a 90.7 grams per 
pound (g/lb) (200 g/kilogram (kg)) monensin Type A medicated article 
for making Type B and C medicated cattle and goat feeds.

EFFECTIVE DATE: March 26, 1997.

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, filed 
supplemental NADA 95-735, which provides for using a 90.7 g/lb (200 g/
kg) monensin Type A medicated article to make monensin Type B and C 
medicated cattle and goat feeds.
    The supplemental NADA is approved as of February 6, 1997, and the 
regulations are amended in 21 CFR

[[Page 14304]]

558.355(b)(7) and (b)(14) to reflect the approval.
    The supplemental approval is for a higher concentration of Type A 
article to make currently approved Type B and C feeds, and it does not 
affect the basis of approval of, or conditions of use in, the currently 
approved application. Therefore, no additional safety or effectiveness 
data were required for this approval, and a freedom of information 
summary is not required. A summary of the data and information 
submitted to support the previously approved application may be seen in 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 
p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food 
producing animals does not qualify for marketing exclusivity because 
the supplement does not contain substantial evidence of effectiveness 
of the drug involved, any studies of animal safety, or human food 
safety studies (other than bioequivalence or residue studies) required 
for approval of the supplement and conducted or sponsored by the 
applicant.
    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 
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 (b)(7) by 
removing the phrase ``and 80'' and adding in its place ``80, and 90.7'' 
and in paragraph (b)(14) by removing the phrase ``and 80'' and adding 
in its place ``, 80, and 90.7''.

    Dated: March 13, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-7546 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F