[Federal Register Volume 61, Number 166 (Monday, August 26, 1996)]
[Rules and Regulations]
[Pages 43654-43656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Bambermycins

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 a supplemental new animal drug 
application (NADA) filed by Hoechst-Roussel Agri-Vet Co. The 
supplemental NADA provides for using bambermycins Type A medicated 
articles to make a bambermycins free-choice Type C medicated loose 
mineral feed for pasture cattle (slaughter, stocker, and feeder) for 
increased rate of weight gain.

EFFECTIVE DATE: August 26, 1996.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0217.

[[Page 43655]]

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Rt. 202-206, 
P.O. Box 2500, Somerville, NJ 08876-1258, filed supplemental NADA 141-
034, which provides for using 10-grams per pound (g/lb) 
Flavomycin (bambermycins) Type A medicated articles to make 
free-choice Type C medicated loose mineral feeds containing 120 g/ton 
bambermycins for pasture cattle (slaughter, stocker, and feeder). The 
Type C feeds are fed at 10- to 20-milligrams (mg) bambermycins per head 
per day for increased rate of weight gain. The supplemental NADA is 
approved as of August 26, 1996, and the regulations are amended in 21 
CFR 558.95(b)(4)(iii) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    -As required by 21 CFR 510.455, use of a Type A medicated article 
to make a free-choice Type C medicated feed/medicated loose mineral 
feed requires an approved Form FDA 1900.
    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.
    -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 qualifies 
for 3 years of marketing exclusivity beginning August 26, 1996, because 
it 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.
    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 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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    -2. Section 558.95 is amended by adding new paragraph (b)(4)(iii) 
to read as follows:

Sec. 558.95   Bambermycins.

* * * * *
    -(b) * * *
    -(4) * * *
    -(iii) Used as a free-choice Type C medicated loose mineral feed 
for pasture cattle (slaughter, stocker, and feeder) as follows:
    -(a)  Specifications.

                                                                        
------------------------------------------------------------------------
      Ingredient         International Feed No.          Percent        
------------------------------------------------------------------------
Deflorinated phosphate                                                  
 (20.5% calcium, 18.5%                                                  
 phosphorus)                           6-01-080                    42.50
Sodium chloride (salt)                 6-04-152                    20.10
Calcium carbonate (38%                                                  
 calcium)                              6-01-069                    15.24
Corn distillers dried                                                   
 grains w/solubles                     5-28-236                     9.57
Magnesium oxide                        6-02-756                     5.15
Vitamin and trace                                                       
 mineral premix *                     .........                     3.72
Mineral oil                           .........                     1.00
Yeast (primary                                                          
 dehydrated yeast)                     7-05-533                     0.75
Bambermycins Type A                                                     
 article (10 g/lb)                    .........                     0.60
Iron oxide                             6-02-431                     0.50
Magnesium sulfate                                                       
 (67%)                                 6-02-758                     0.32
Selenium premix (270                                                    
 mg/lb) *                             .........                     0.21
Copper sulfate                         6-01-720                     0.18
Potassium sulfate                                                       
 (0.33%)                               6-06-098                     0.16
------------------------------------------------------------------------
*Content of 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.    
  Selenium must comply with 21 CFR 573.920. Ethylenediamine             
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides  
  Sec. 651.100 (CPG 7125.18).                                           





[[Page 43656]]


    -(b)  Amount per ton. 120 grams.
    -(c) Indications for use. For increased rate of weight gain.
    -(d)  Limitations. For free-choice feeding to pasture cattle 
(slaughter, stocker, and feeder). Feed a nonmedicated commercial 
mineral product for 6 weeks to stabilize consumption between 2.66 and 
5.33 ounces per head per day. Feed continuously to provide 10- to 20-
milligrams bambermycins per head per day. Not for use in animals 
intended for breeding. Each use of this free-choice Type C medicated 
feed must be the subject of an approved Form FDA 1900 as required by 21 
CFR 510.455.
* * * * *

    Dated: August 16, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-21654 Filed 8-23-96; 8:45 am]
BILLING CODE 4160-01-F