[Federal Register Volume 60, Number 153 (Wednesday, August 9, 1995)]
[Rules and Regulations]
[Pages 40453-40455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19634]



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[[Page 40454]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Animal Drugs, Feeds, and Related Products; Oxytetracycline 
Hydrochloride Soluble Powder

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 an abbreviated new animal drug 
application (ANADA) filed by Rhone Merieux Canada, Inc. The ANADA 
provides for the use of a generic oxytetracycline hydrochloride soluble 
powder administered orally in drinking water for the control of certain 
diseases of chickens and turkeys and the treatment and control of 
certain diseases of swine, all susceptible to oxytetracycline.

EFFECTIVE DATE: August 9, 1995.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Rhone Merieux Canada, Inc., 345 Boul. Labbe 
Blvd., North Victoriaville, QC, G6P 1B1, Canada, filed ANADA 200-144 
which provides for use of oxytetracycline hydrochloride soluble powder 
in drinking water of chickens, turkeys, and swine. The medicated 
drinking water is used as follows: (1) Chickens for control of 
infectious synovitis caused by Mycoplasma synoviae susceptible to 
oxytetracycline; control of chronic respiratory disease (CRD) and air 
sac infections caused by M. gallisepticum and Escherichia coli 
susceptible to oxytetracycline; control of fowl cholera caused by 
Pasteurella multocida susceptible to oxytetracycline; (2) turkeys for 
control of hexamitiasis caused by Hexamita meleagridis susceptible to 
oxytetracycline; infectious synovitis caused by M. synoviae susceptible 
to oxytetracycline; and control of complicating bacterial organisms 
associated with blue comb (transmissible enteritis; coronaviral 
enteritis) susceptible to oxytetracycline; (3) swine for control and 
treatment of bacterial enteritis caused by E. coli and Salmonella 
choleraesuis and bacterial pneumonia caused by P. multocida susceptible 
to oxytetracycline; and (4) breeding swine for control and treatment of 
leptospirosis (reducing the incidence of abortions and shedding of 
leptospira) caused by Leptospira pomona susceptible to oxytetracycline.
    Approval of ANADA 200-144 for oxytetracycline soluble powder is a 
generic copy of I. D. Russell's NADA 130-435 (Oxytet Soluble). The 
ANADA is approved as of June 26, 1995, and the regulations in 
Sec. 520.1660d (21 CFR 520.1660d) are amended to reflect the approval. 
The basis for approval is discussed in the freedom of information 
summary.
    Also, Rhone Merieux Canada, Inc., has not been previously listed in 
21 CFR 510.600(c) as sponsor of an approved application. That section 
is amended to add entries for the firm.
    In addition, the regulation contains an outdated paragraph citing 
the National Academy of Sciences/National Research Council (NAS/NRC) 
status of these products. The Generic Animal Drug and Patent Term 
Restoration Act of 1988 changed that status, therefore, 
Sec. 520.1660d(c)(2) is removed and reserved.
    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 data and information submitted to support approval of this 
application 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 carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above), between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 510

     Administrative practice and procedure, Animal drug, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.
    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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Rhone Merieux Canada, Inc.,'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``047015'' to read as follows:

Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

                                                                                                                
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                      Firm name and address                                      Drug labeler code              
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Rhone Merieux Canada, Inc., 345 Boul. Labbe Blvd., North,                                                       
 Victoriaville, QC, G6P 1B1 Canada..............................                                         047015 
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    (2) * * *

                                                                                                                

[[Page 40455]]
                                                                        
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      Drug labeler code                  Firm name and address          
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  *                    *                    *                    *      
                   *                    *                    *          
047015.......................  Rhone Merieux Canada, Inc., 345 Boul.    
                                Labbe Blvd., North, Victoriaville, QC   
                                G6P 1B1 Canada.                         
  *                    *                    *                    *      
                   *                    *                    *          
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec. 520.1660d  [Amended]

    2. Section 520.1660d Oxytetracycline hydrochloride soluble powder 
is amended in paragraph (b)(2) by adding the phrase ``and 047015'' 
after ``017144,'' and by removing and reserving paragraph (c).

    Dated: July 31, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-19634 Filed 8-8-95; 8:45 am]
BILLING CODE 4160-01-F