[Federal Register Volume 62, Number 53 (Wednesday, March 19, 1997)]
[Rules and Regulations]
[Pages 12951-12952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6876]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene 
Disalicylate and Chlortetracycline

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 new animal drug application 
(NADA) filed by Alpharma Inc. The NADA provides for using currently 
approved, single ingredient, Type A medicated articles in making 
combination drug, Types B and C medicated, swine feeds containing 
bacitracin methylene disalicylate and chlortetracycline. The Type C 
medicated feed is used for increased rate of weight gain and improved 
feed efficiency due to the activity of bacitracin, and treatment of 
enteritis and pneumonia caused by certain bacteria susceptible to 
chlortetracycline.

EFFECTIVE DATE: March 19, 1997.

FOR FURTHER INFORMATION CONTACT:  George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION:  Alpharma Inc., One Executive Dr., Fort Lee, 
NJ 07024, filed NADA 141-059, which provides for combining separately 
approved, Type A medicated articles containing BMD<Register> 
(bacitracin methylene disalicylate (bacitracin MD)) and CTC 
(chlortetracycline) in making combination drug, Type C medicated swine 
feed. The Type C medicated feed

[[Page 12952]]

contains 10 to 30 grams (g) of bacitracin MD and approximately 400 g of 
CTC per ton varying with body weight and food consumption to provide 10 
milligrams of CTC per pound of body weight per day. The feed is 
indicated for increased rate of weight gain and improved feed 
efficiency due to the activity of bacitracin, and treatment of 
bacterial enteritis caused by Escherichia coli and Salmonella 
choleraesuis and bacterial pneumonia caused by Pasteurella multocida 
susceptible to CTC. The NADA is approved as of September 18, 1996, and 
the regulations are amended by revising 21 CFR 558.76(d)(1) and by 
adding 21 CFR 558.128(c)(3)(xiv) to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    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)(ii) of the Federal Food, Drug, and Cosmetic 
Act, this approval does not qualify for marketing exclusivity because 
the application contains no new clinical or field investigations (other 
than bioequivalence or residue studies) essential to the approval of 
the application and conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(ii) 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 558.76 is amended in the table in paragraph (d)(1) under 
entry (iv) by adding a new item for Chlortetracycline approximately 400 
to read as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (1) * * *

                                                                                                                
----------------------------------------------------------------------------------------------------------------
   Bacitracin methylene                                                                                         
 disalicylate in grams per   Combination in grams   Indications for use        Limitations           Sponsor    
            ton                    per ton                                                                      
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
(iv) 10 to 30               * * *                  * * *                  * * *                  * * *          
                            Chlortetracycline      Swine; for increased   Feed for not more      046573         
                             approximately 400,     rate of weight gain    than 14 days to                      
                             varying with body      and improved feed      provide 10                           
                             weight and food        efficiency; for        milligrams of                        
                             consumption to         treatment of           chlortetracycline                    
                             provide 10             bacterial enteritis    per pound of body                    
                             milligrams per pound   caused by              weight per day; as                   
                             of body weight per     Escherichia coli and   chlortetracycline                    
                             day.                   Salmonella             provided by No.                      
                                                    choleraesuis and       046573 in Sec.                       
                                                    bacterial pneumonia    510.600(c) of this                   
                                                    caused by              chapter.                             
                                                    Pasteurella                                                 
                                                    multocida                                                   
                                                    susceptible to                                              
                                                    chlortetracycline.                                          
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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* * * * *
    3. Section 558.128 is amended by adding new paragraph (c)(3)(xiv) 
to read as follows:


Sec. 558.128  Chlortetracycline.

* * * * *
    (c) * * *
    (3) * * *
    (xiv) Bacitracin methylene disalicylate in accordance with 
Sec. 558.76.

    Dated: February 6, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-6876 Filed 3-18-97; 8:45 am]
BILLING CODE 4160-01-F