[Federal Register Volume 61, Number 200 (Tuesday, October 15, 1996)]
[Rules and Regulations]
[Pages 53614-53615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Monensin Blocks

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 Cooperative Research Farms and PM Ag 
Products, Inc. The supplemental NADA's provide that use of monensin 
medicated free-choice feed blocks for pasture cattle weighing less than 
400 pounds (lb) for increased rate of weight gain is no longer 
contraindicated.

EFFECTIVE DATE: October 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.


[[Page 53615]]


SUPPLEMENTARY INFORMATION: Cooperative Research Farms, P.O. Box 69, 
Charlotteville, NY 12036, is sponsor of NADA 119-253. PM Ag Products, 
Inc., 1055 West 175th St., Homewood, IL 60430, is sponsor of NADA 109-
471. The firms filed supplemental NADA's that provide for removal of 
the limitation concerning use of the product for pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers) 
weighing less than 400 lb for increased rate of weight gain. The 
supplemental NADA's are approved as of September 10, 1996, and the 
regulations are amended in 21 CFR 520.1448a(a)(4)(iii) and (d)(4)(iii) 
to reflect the approvals. The approval is based on the data included in 
Elanco's supplemental NADA 95-735 that removed the 400 lb limitation 
for use of monensin Type A articles to make monensin Type C feeds in 21 
CFR 558.355(f)(3)(iii).
    No new safety and effectiveness data were submitted to support 
approval of these supplemental applications. Therefore, a freedom of 
information (FOI) summary as described in 21 CFR part 20 and 21 CFR 
514.11(e)(2)(ii) is not required. The FOI summary for Elanco's 
supplemental NADA 95-735 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)), these approvals do not 
qualify for marketing exclusivity because the approvals 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.
    The agency has determined under 21 CFR 25.24(d)(1)(vi) 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 520

    Animal drugs.
    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 520 is 
amended as follows:

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 paragraphs 
(a)(4)(iii) and (d)(4)(iii) by removing the phrase ``weighing more than 
400 pounds.''

    Dated: October 1, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-26374 Filed 10-11-96; 8:45 am]
BILLING CODE 4160-01-F