[Federal Register Volume 61, Number 95 (Wednesday, May 15, 1996)]
[Rules and Regulations]
[Pages 24443-24444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12156]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 558


Animal Drugs, Feeds, and Related Products; 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 supplemental new animal drug 
applications (NADA's) filed by Elanco Animal Health, Division of Eli 
Lilly and Co., Moorman Manufacturing Co., and Farmland Industries, Inc. 
Elanco's supplemental NADA provides for use of monensin Type C 
medicated feeds fed to pasture cattle weighing less than 400 pounds 
(lb) for increased rate of weight gain. Moorman's and Farmland's 
supplemental NADA's provide for use of monensin blocks for pasture 
cattle weighing less than 400 lb for increased rate of weight gain.

EFFECTIVE DATE: May 15, 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 monensin Type A 
medicated articles to make monensin Type C medicated feeds containing 
25 to 400 grams per ton monensin as monensin sodium to be fed at 50 to 
200 milligrams per head per day to pasture cattle (slaughter, stocker, 
feeder, and dairy and beef replacement heifers) weighing less than 400 
lb for increased rate of weight gain. Moorman Manufacturing Co., 
Quincy, IL 62301, filed supplemental NADA 115-581, and Farmland 
Industries, Inc., Kansas City, MO 64116, filed supplemental NADA 118-
509, providing for free-choice feeding of monensin blocks, all to 
pasture cattle weighing less than 400 lb for increased rate of weight 
gain.

    The supplemental NADA's provide for removal of the restriction 
concerning feeding of the products to animals weighing less than 400 lb 
body weight as currently approved. The supplemental NADA's are approved 
as of March 15, 1996, and the regulations are amended in 21 CFR 
520.1448a(c) and 558.355(f)(3)(iii) and (f)(3)(v) to reflect the 
approvals. The basis for approval is discussed in the freedom of 
information summary for Elanco's supplemental NADA 95-735.
    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 Elanco Animal 
Health's supplemental NADA 95-735 qualifies for 3 years of marketing 
exclusivity beginning March 15, 1996, because the supplement contains 
reports of new clinical or field investigations (other than 
bioequivalence or residue studies) essential to the approval and 
conducted or sponsored by the applicant. Marketing exclusivity applies 
only to the new use of the product.
    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 Moorman's 
supplemental NADA 115-581 and Farmland's supplemental NADA 118-509 do 
not qualify for marketing exclusivity because the supplements do 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.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a 
summary of safety and effectiveness data and information submitted to 
support approval of this 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.
    The basis of approval of Moorman's and Farmland's supplemental 
NADA's are by authorization to reference data and information in 
Elanco's supplemental NADA 95-735. Therefore, a freedom of information 
summary of the data and information required for approval of these 
NADA's is available under Elanco's supplemental NADA 95-735.
    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

 21 CFR Part 520

     Animal drugs.

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 parts 520 and 
558 are amended as follows:

[[Page 24444]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. 520.1448a  [Amended]

    2. Section 520.1448a Monensin blocks is amended in paragraph 
(c)(4)(iii) by removing the phrase ``weighing more than 400 pounds''.

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

    3. 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]

    4. Section 558.355 Monensin is amended in paragraph (f)(3)(iii)(b) 
and (f)(3)(v)(b) by removing the phrase ``weighing more than 400 
pounds''.

    Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-12156 Filed 5-14-96; 8:45 am]
BILLING CODE 4160-01-F