[Federal Register Volume 66, Number 57 (Friday, March 23, 2001)]
[Rules and Regulations]
[Pages 16125-16126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin

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 two supplemental new animal 
drug applications (NADA's) filed by Elanco Animal Health. These 
supplemental NADA's provide for using tylosin or monensin and tylosin 
single-ingredient Type A medicated articles to make tylosin liquid Type 
B medicated feeds or combination drug liquid Type B medicated feeds. 
The liquid Type B medicated feeds are used to make dry Type C medicated 
feeds for cattle.

DATES: This rule is effective March 23, 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: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
supplemental NADA 12-491 that provides for use of TYLAN (40 
or 100 grams per pound (g/lb) tylosin phosphate) Type A medicated 
articles to make liquid Type B medicated feeds. The tylosin liquid Type 
B medicated feeds are, in turn, used to make dry Type C medicated feeds 
for reduction of the incidence of liver abscesses caused by 
Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in 
beef cattle. Elanco Animal Health also filed supplemental NADA 104-646 
that provides for use of RUMENSIN (20, 30, 45, 60, 80, or 
90.7 g/lb monensin activity as monensin sodium) and TYLAN 
Type A medicated articles to make liquid combination drug Type B 
medicated feeds. The combination drug liquid Type B medicated feeds 
are, in turn, used to make dry Type C medicated feeds used for improved 
feed efficiency and reduction of the incidence of liver abscesses 
caused by F. necrophorum and A. (Corynebacterium) pyogenes in cattle 
fed in confinement for slaughter. The supplemental NADA's are approved 
as of February 2, 2001, and the regulations are amended in 21 CFR

[[Page 16126]]

558.355 and 558.625 to reflect the approval.
    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 in paragraph (f)(3)(ii)(b) by adding 
a new sentence after the second sentence to read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) *  *  *
    (3) *  *  *  
    (ii) *  *  *  
    (b) *  *  *   Combination drug liquid Type B medicated feeds may be 
used to manufacture dry Type C medicated feeds and shall conform to 
mixing instructions as in Sec. 558.625 (c).
* * * * *
    3. Section 558.625 is amended by adding paragraph (c) to read as 
follows:


Sec. 558.625  Tylosin.

* * * * *
    (c) Special considerations. (1) Type C medicated feeds for cattle 
may be manufactured from tylosin liquid Type B medicated feeds which 
have a pH between 4.5 and 6.0 and which bear appropriate mixing 
directions as follows:
    (i) For liquid Type B feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for no fewer than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (ii) For liquid Type B feeds stored in mechanical, air, or other 
agitation-type tank systems: Agitate immediately prior to use for no 
fewer than 10 minutes, creating a turbulence at the bottom of the tank 
that is visible at the top. Agitate daily as described even when not 
used.
    (2) Tylosin liquid Type B medicated feeds used to make Type C 
medicated feeds for cattle may be manufactured from tylosin Type A 
medicated articles according to the following mixing directions:
    (i) Presolubilize tylosin in 50 percent urea for approximately 1 
hour prior to adding any feed components or other active ingredients.
    (ii) Maintain a pH between 4.5 and 6.0.
    (3) Tylosin liquid Type B medicated feeds must bear an expiration 
date of 8 weeks after the date of manufacture.
* * * * *

    Dated: March 8, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-7182 Filed 3-22-01; 8:45 am]
BILLING CODE 4160-01-S