[Federal Register Volume 60, Number 238 (Tuesday, December 12, 1995)]
[Rules and Regulations]
[Pages 63622-63623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30124]



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


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.

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

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 an approved monensin 
Type A medicated article to make a revised formulation of a monensin 
Type C medicated feed/free-choice mineral granule fed to pasture cattle 
for increased rate of weight gain.

EFFECTIVE DATE: December 12, 1995.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2701.

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 80 grams(g) per 
pound monensin Type A articles to make a monensin Type C medicated 
feed/free-choice mineral granule containing 1,620 g per ton monensin. 
The Type C feed/free-choice mineral granules are fed to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers) 
for increased rate of weight gain. The supplemental NADA provides for a 
revised formulation Type C free-choice mineral granule. The revised 
formulation does not affect the safety or effectiveness data and 
information upon which the application is approved. The supplemental 
NADA is approved as of December 12, 1995, and the regulations are 
amended in 21 CFR 558.355 by adding new paragraph (f)(3)(x) to reflect 
the approval.
    Use of a Type A medicated article to make a free-choice Type C 
medicated feed/ mineral granule requires an approved Form FDA 1900 as 
in 21 CFR 510.455.
    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 does not 
qualify for marketing exclusivity because the supplement does not 
contain reports of new clinical or field investigations or new human 
food safety studies (other than bioequivalence or residue studies) 
essential to the approval and conducted or sponsored by the applicant.
    A freedom of information summary for this approval is not required 
because it involves approval of a revised formulation which does not 
affect the basis of approval of the product. A summary of the data and 
information submitted to support the original approval may be seen in 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 
p.m., Monday through Friday.
    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:


[[Page 63623]]

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    2. Section 558.355 is amended by adding new paragraph (f)(3)(x) to 
read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) *    *    *
    (3) *    *    *
    (x) Amount per ton. Monensin, 1,620 grams as monensin sodium (810 
milligrams per pound).
    (a) Indications for use. For increased rate of weight gain.
    (b) Specifications. Use as free-choice Type C medicated feed 
formulated as mineral granules as follows:-

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                           Ingredient                              Percent          International feed no.      
----------------------------------------------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus, 15% calcium)                   29.49                            6-01-080 
Sodium chloride (salt)                                                24.25                            6-04-152 
Dried cane molasses                                                   20.0                             4-04-152 
Ground limestone (33% calcium)                                        13.75                            6-02-632 
Cane molasses                                                          3.0                             4-04-696 
Processed grain by-products (as approved by AAFCO)                     5.0                                      
Vitamin/trace mineral premix\1\                                        2.5                                      
Monensin Type A article, 80 grams per pound                            1.01                                     
Antidusting oil                                                        1.0                                      
----------------------------------------------------------------------------------------------------------------
\1\Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used  
  for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. The amount of 
  selenium and ethylenediamine dihydroiodide (EDDI) must comply with the published requirements. (For selenium  
  see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).)                                                

    (c) Limitations. Medicated mineral granules to be fed free-choice 
to pasture cattle (slaughter, stocker, feeder, and dairy and beef 
replacement heifers) weighing more than 400 pounds. Feed continuously 
on a free-choice basis at the rate of 50 to 200 milligrams per head per 
day. During the first 5 days of feeding, cattle should receive no more 
than 100 milligrams per day. Do not feed additional salt or minerals. 
Do not mix with grain or other feeds. Monensin is toxic to cattle when 
consumed at higher than approved levels. Stressed and/or water deprived 
cattle should be adapted to the pasture and to unmedicated mineral 
supplement before using this product. Do not feed to lactating dairy 
cattle. Do not allow horses, other equines, mature turkeys, or guinea 
fowl access to feed containing monensin. Ingestion of monensin by 
horses and guinea fowl has been fatal. The product's effectiveness in 
cull cows and bulls has not been established. Each use of this free-
choice Type C feed must be the subject of an approved medicated feed 
application (MFA or Form FDA 1900) or supplemental MFA as required by 
Sec. 510.455 of this chapter.
* * * * *

    Dated: November 22, 1995.
Nicholas E. Weber,
Director, Division of Chemistry, Office of New Animal Drug Evaluation, 
Center for Veterinary Medicine.
[FR Doc. 95-30124 Filed 12-11-95; 8:45 am]
BILLING CODE 4160-01-F