[Federal Register Volume 66, Number 236 (Friday, December 7, 2001)]
[Rules and Regulations]
[Page 63500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30298]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Monensin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 MoorMan's, Inc. The supplemental NADA 
provides for use of approved monensin Type A medicated articles to make 
free-choice, medicated feed blocks used for prevention and control of 
coccidiosis caused by Eimeria bovis and E. zuernii in pasture cattle.

DATES: This rule is effective December 7, 2001.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223.

SUPPLEMENTARY INFORMATION: MoorMan's, Inc., 1000 North 30th St., 
Quincy, IL 62305-3115, filed a supplement to NADA 115-581 that provides 
for use of monensin Type A medicated articles to make free-choice, 
medicated protein/mineral blocks (MoorMan's Mintrate Blonde Block RU 
and MoorMan's Mintrate Red Block RU) used for increased rate of weight 
gain in cattle on pasture (slaughter, stocker, feeder cattle, and dairy 
and beef replacement heifers) which may require supplemental feed. The 
supplemental NADA provides for use of these medicated feed blocks for 
the prevention and control of coccidiosis caused by Eimeria bovis and 
E. zuernii in pasture cattle. The supplemental NADA is approved as of 
September 27, 2001, and the regulations are amended in 21 CFR 558.355 
to reflect the approval. The basis of approval is discussed in the 
freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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: 21 U.S.C. 360b, 371.
    2. Section 558.355 is amended by revising paragraph (f)(3)(v)(a) to 
read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * * 
    (3) * * * 
    (v) * * * 
    (a) Indications for use. For increased rate of weight gain and for 
prevention and control of coccidiosis caused by Eimeria bovis and E. 
zuernii.
* * * * *

    Dated: November 8, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-30298 Filed 12-6-01; 8:45 am]
BILLING CODE 4160-01-S