96-17169. Animal Drugs, Feeds, and Related Products; Chlortetracycline  

  • [Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
    [Rules and Regulations]
    [Pages 35949-35958]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-17169]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Parts 510 and 558
    
    
    Animal Drugs, Feeds, and Related Products; Chlortetracycline
    
    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 five supplemental new animal 
    drug applications (NADA's) filed by Hoffmann-LaRoche, Inc., Pfizer, 
    Inc., ALPHARMA, Inc., ADM Animal Health & Nutrition Div., and PennField 
    Oil Co. The supplemental NADA's provide for the safe and effective use 
    of Type A medicated articles containing chlortetracycline (CTC) in the 
    feed of chickens, turkeys, swine, sheep, and calves, beef and 
    nonlactating dairy cattle for improved production efficiency and for 
    control and treatment of certain bacterial diseases susceptible to CTC. 
    The approvals reflect compliance with results of the National Academy 
    of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study 
    Group's (DESI) evaluation of the drug's effectiveness, and FDA's 
    conclusions concerning that evaluation.
    
    EFFECTIVE DATE: July 9, 1996.
    
    FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
    Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
    Rockville, MD 20855, 301-594-1623.
    
    SUPPLEMENTARY INFORMATION: The following sponsors have submitted 
    supplements to their approved NADA's:
         Hoffmann-LaRoche, Inc., Nutley, NJ 07110 (formerly held by 
    American Cyanamid Co.), to NADA 48-761, which covers the Type A 
    medicated articles: Aureomix 293 (50 grams of 
    chlortetracycline hydrochloride per pound (g CTC HCl/lb)) and 
    Aureomycin 50, 70, 80, 90, and 100 (contain CTC calcium 
    complex equivalent to the indicated g/lb concentrations of CTC HCl);
         Pfizer, Inc., 235 East 42d St., New York, NY 10017, to 
    NADA 92-286, which covers the Type A medicated articles CLTC 
    10, 20, 30, 50, and 70 (contain CTC calcium complex equivalent to the 
    indicated g/lb concentrations of CTC HCl) and to NADA 92-287, which 
    covers the Type A medicated articles CLTC 50 MR and 100 MR 
    (contain CTC calcium complex equivalent to the indicated g/lb 
    concentrations of CTC HCl);
         ALPHARMA, Inc. (formerly A. L. Laboratories), One 
    Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, to NADA 46-699, which 
    covers the Type A medicated articles: CTC 100 MR (100 g CTC HCl/lb) and 
    CTC 10, CTC 50, CTC 65, CTC 70, and Micro CTC 100 (contains CTC calcium 
    complex equivalent to the indicated g/lb concentrations of CTC HCl);
         ADM Animal Health & Nutrition Div., P.O. Box 2508, Fort 
    Wayne, IN 46801-2508 (formerly Feed Specialties Co., Inc.), to NADA 48-
    480, which covers the Type A medicated article ChloratetTM 50 
    (contains CTC calcium complex equivalent to 50 g CTC HCI/lb); and
         PennField Oil Co., 14040 Industrial Rd., Omaha, NE 68137, 
    to NADA 138-935, which covers the Type A medicated articles: 
    Chlortetracycline Premixes 50, 60, 70, 80, 100 (all contain CTC calcium 
    complex equivalent to the indicated g/lb concentrations of CTC HCl), 
    and 100 MR (100 g CTC HCl/lb).
        The drug products were the subject of a NAS/NRC DESI evaluation of 
    effectiveness (DESI 0113NV). The findings were published in the Federal 
    Register of July 21, 1970 (35 FR 11646). NAS/NRC evaluated the drug 
    products as probably effective for growth promotion and feed efficiency 
    and for the treatment of animal diseases caused by pathogens sensitive 
    to chlortetracycline. NAS/NRC stated that:
        (1) Claims made regarding ``for prevention of'' or ``to 
    prevent'' should be replaced with ``as an aid in the control of'' or 
    ``to aid in the control of'''; (2) claims for growth promotion or 
    stimulation are disallowed and claims for faster gains and/or feed 
    efficiency should be stated as ``may result in faster gains and/or 
    improved feed efficiency under appropriate conditions''; (3) each 
    disease claim should be properly qualified as ``appropriate for use 
    in (name of disease) caused by pathogens sensitive to (name of 
    drug)''; if the disease cannot be so qualified the claim must be 
    dropped; (4) claims pertaining to egg production and hatchability 
    should be changed to ``May aid in maintaining egg production and 
    hatchability, under appropriate conditions, by controlling 
    pathogenic microorganisms''; (5) the labels should warn that treated 
    animals must actually be consuming enough medicated water or 
    medicated feed to provide a therapeutic dosage under the conditions 
    that prevail and, as a precaution, state the desired oral dose per 
    unit of animal weight per day for each species as a guide to 
    effective usage of the preparation in drinking water or feed; and 
    (6) effective blood levels are required for each recommended dosage.
    
        FDA concurred with the NAS/NRC findings, interpreting the phrase 
    ``* * * cannot be so qualified * * *'' in above item (3) to mean ``* * 
    * is not supported by adequate data * * *'' FDA reviewed all available 
    effectiveness data of products subject to the evaluation and concluded 
    that the data supported effectiveness for the control and treatment of 
    certain bacterial diseases susceptible to CTC in chickens, turkeys, 
    swine, sheep, calves, and cattle.
    
        The NAS/NRC DESI evaluation is concerned only with the drugs' 
    effectiveness and safety to the treated animal. It does not take into 
    account the safety for food use of food derived from drug-treated 
    animals. Nothing herein will constitute a bar to further proceedings 
    with respect to questions of safety of the drugs or their metabolites 
    in food products derived from treated animals.
    
        The five subject sponsors filed supplements that revised the 
    labeling of their products to comply with the findings of the NAS/NRC 
    review and FDA's conclusions concerning those findings. The 
    supplemental NADA's were approved as of February 16, 1996. The 
    revisions to Sec. 558.128 (21 CFR 558.128) list the NAS/NRC and FDA-
    approved conditions of use for CTC-containing Type A medicated 
    articles.
    
        Products which comply with the NAS/NRC findings and FDA's 
    conclusions regarding those findings are eligible for copying under the 
    Generic Animal Drug and Patent Term Restoration Act (GADPTRA) (see the 
    eighth in a series of policy letters issued to facilitate 
    implementation of GADPTRA that published in the Federal Register of 
    August 21, 1991 (56 FR 41561). Accordingly, sponsors may now
    
    [[Page 35950]]
    
    obtain approval of abbreviated new animal drug applications (ANADA's) 
    for these CTC Type A medicated articles.
        FDA has incorporated within Sec. 558.128 a warning against use of 
    CTC feed in veal calves as part of a general effort to distinguish 
    between ruminating calves and preruminating calves based on information 
    indicating that withdrawal periods established in ruminating calves may 
    not be adequate for preruminating calves.
        Also, the agency has removed in Sec. 558.128 the use of the fixed 
    combination for chlortetracycline and sulfamethazine to treat beef 
    cattle. FDA has recodified this approval in a separate section 
    (Sec. 558.140 (21 CFR 558.140)), as has been done for other fixed 
    combinations. In addition, the agency is using this occasion, of the 
    DESI finalization of the CTC Type A medicated articles, to amend those 
    portions of the regulations containing CTC combination feeds (see list 
    in Sec. 558.128(c)(5)) to revise the CTC claim language to make it 
    consistent with the NAS/NRC and FDA-approved conditions of use.
        Furthermore, the agency is deleting the citations for CTC in 
    Sec. 510.515 (21 CFR 510.515). Section 510.515 defines antibiotic drugs 
    permitted in feed that were exempt from the requirement of 
    certification. GADPTRA (Pub. L. 100-670) signed on November 16, 1988, 
    removed the requirement for certification of antibiotic drugs for 
    animal use. In fact, in a final rule published in the Federal Register 
    of May 26, 1989 (54 FR 22741), the agency revoked the antibiotic 
    procedural regulations. The published exemption constituted a sanction 
    by the agency for use of the listed antibiotics. With the finalization 
    of the DESI evaluation of the CTC products, the sanction is obsolete. 
    Also, by deleting the CTC listing from Sec. 510.515, the agency is 
    correcting an error introduced when the regulation was published. Our 
    records indicate that concurrent cites to oxytetracycline in 
    Sec. 510.515(b)(7)(i) and (b)(17)(i) were incorrect, as oxytetracycline 
    was not considered a certifiable antibiotic animal drug; therefore, it 
    was incorrectly listed in Sec. 510.515.
        In the Federal Register of October 21, 1977 (42 FR 56264), the then 
    Bureau of Veterinary Medicine issued a notice of opportunity for a 
    hearing (NOOH) on a proposal to withdraw approval of certain NADA's 
    listed in Sec. 558.15, for most subtherapeutic uses of tetracycline 
    (CTC and oxytetracycline) in animal feed. The NOOH was issued in 
    response to scientific research suggesting that subtherapeutic use of 
    such drugs has contributed to the pool of antibiotic-resistant 
    pathogenic microorganisms in food animals. Furthermore, research 
    indicated that the drug resistance could be transferred to pathogenic 
    organisms in humans. The NOOH is still pending and approval of these 
    supplements to finalize the DESI review process for CTC Type A 
    medicated articles does not constitute a bar to subsequent action to 
    withdraw approval on the grounds cited in the outstanding NOOH.
        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)), these approvals for food-
    producing animals do not qualify for marketing exclusivity because the 
    supplemental applications do not contain reports of new clinical or 
    field investigations (other than bioequivalence or residue studies) and 
    new human food safety studies (other than bioequivalence or residue 
    studies) essential to the approvals and conducted or sponsored by the 
    applicant.
        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 drugs, Labeling, 
    Reporting and recordkeeping requirements.
    
    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 parts 510 and 
    558 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).
    
    Sec. 510.515  [Amended]
    
        2. Section 510.515 Animal feeds bearing or containing new animal 
    drugs subject to the provision of section 512(n) of the act is amended 
    in paragraph (b) by removing and reserving paragraphs (b)(7), (b)(17), 
    (b)(25), and (b)(29); by redesignating paragraphs (b)(10) and (b)(13) 
    as paragraphs (b)(1) and (b)(2); and in the table in paragraph (c) by 
    removing entries 6, 7, and 8 for ``Chlortetracycline.''
    
    PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
    
        3. 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).
    
        4. Section 558.55 is amended in the table in paragraph (d)(2) under 
    entries (i), (ii), and (iv) by revising the items for 
    ``Chlortetracycline 100 to 200'' and by adding new items for 
    ``Chlortetracycline 200 to 400'' to read as follows:
    
    
    Sec. 558.55  Amprolium.
    
    * * * * *
        (d) * * *
        (2) * * *
    
    [[Page 35951]]
    
    
    
                                                                            
    ------------------------------------------------------------------------
      Amprolium in    Combination in   Indications                          
     grams per ton    grams per ton      for use      Limitations    Sponsor
    ------------------------------------------------------------------------
    (i) * * *                                                               
      *                    *                    *                    *      
                       *                    *                    *          
                     Chlortetracycli  Chickens;      Do not feed            
                      ne 100 to 200.   development    to chickens           
                                       of active      producing             
                                       immunity to    eggs for              
                                       coccidiosis;   human                 
                                       control of     consumption.          
                                       infectious     Feed for 7            
                                       synovitis      to 14 d.              
                                       caused by                            
                                       Mycoplasma                           
                                       synoviae                             
                                       susceptible                          
                                       to                                   
                                       chlortetracy                         
                                       cline.                               
                     Chlortetracycli  Chickens;      Do not feed            
                      ne 200 to 400.   development    to chickens           
                                       of active      producing             
                                       immunity to    eggs for              
                                       coccidiosis;   human                 
                                       control of     consumption.          
                                       chronic        Feed for 7            
                                       respiratory    to 14 d.              
                                       disease                              
                                       (CRD) and                            
                                       air sac                              
                                       infection                            
                                       caused by M.                         
                                       gallisepticu                         
                                       m and E.                             
                                       coli                                 
                                       susceptible                          
                                       to                                   
                                       chlortetracy                         
                                       cline.                               
                                                                            
      *                    *                    *                    *      
                       *                    *                    *          
    (ii) * * *                                                              
      *                    *                    *                    *      
                       *                    *                    *          
                     Chlortetracycli  Chickens;      Do not feed            
                      ne 100 to 200.   prevention     to chickens           
                                       of             producing             
                                       coccidiosis    eggs for              
                                       caused by E.   human                 
                                       tenella        consumption.          
                                       only;          Feed for 7            
                                       control of     to 14 d.              
                                       infectious                           
                                       synovitis                            
                                       caused by M.                         
                                       synoviae                             
                                       susceptible                          
                                       to                                   
                                       chlortetracy                         
                                       cline.                               
                     Chlortetracycli  Chickens;      Do not feed            
                      ne 200 to 400.   prevention     to chickens           
                                       of             producing             
                                       coccidiosis    eggs for              
                                       caused by E.   human                 
                                       tenella        consumption.          
                                       only;          Feed for 7            
                                       control of     to 14 d.              
                                       chronic                              
                                       respiratory                          
                                       disease                              
                                       (CRD) and                            
                                       air sac                              
                                       infection                            
                                       caused by M.                         
                                       gallisepticu                         
                                       m and E.                             
                                       coli                                 
                                       susceptible                          
                                       to                                   
                                       chlortetracy                         
                                       cline.                               
                                                                            
      *                    *                    *                    *      
                       *                    *                    *          
    (iv) * * *                                                              
      *                    *                    *                    *      
                       *                    *                    *          
                     Chlortetracycli  Chickens       Do not feed            
                      ne 100 to 200.   where          to chickens           
                                       immunity to    producing             
                                       coccidiosis    eggs for              
                                       is not         human                 
                                       desired;       consumption.          
                                       prevention     Feed for 7            
                                       of             to 14 d.              
                                       coccidiosis;                         
                                       control of                           
                                       infectious                           
                                       synovitis                            
                                       caused by M.                         
                                       synoviae                             
                                       susceptible                          
                                       to                                   
                                       chlortetracy                         
                                       cline.                               
                     Chlortetracycli  Chickens       Do not feed            
                      ne 200 to 400.   where          to chickens           
                                       immunity to    producing             
                                       coccidiosis    eggs for              
                                       is not         human                 
                                       desired;       consumption.          
                                       control of     Feed for 7            
                                       chronic        to 14 d.              
                                       respiratory                          
                                       disease                              
                                       (CRD) and                            
                                       air sac                              
                                       infection                            
                                       caused by M.                         
                                       gallisepticu                         
                                       m and E.                             
                                       coli                                 
                                       susceptible                          
                                       to                                   
                                       chlortetracy                         
                                       cline.                               
      *                    *                    *                    *      
                       *                    *                    *          
    ------------------------------------------------------------------------
    
    * * * * *
        5. Section 558.58 is amended in the table in paragraph (d)(1) by 
    revising entry (iv) for the items ``Chlortetracycline 100 to 200'' and 
    ``Chlortetracycline 200'' to read as follows:
    
    
    Sec. 558.58   Amprolium and ethopabate.
    
    * * * * *
        (d) *  *  *
        (1) *  *  *
    
    [[Page 35952]]
    
    
    
                                                                            
    ------------------------------------------------------------------------
     Amprolium and                                                          
     ethopabate in   Combination in   Indications   Limitations    Sponsor  
     grams per ton    grams per ton     for use                             
    ------------------------------------------------------------------------
      *                    *                    *                    *      
                       *                    *                    *          
    (iv) * * *                                                              
      *                    *                    *                    *      
                       *                    *                    *          
                                                                            
                     Chlortetracycl  For chickens  Do not feed              
                      ine 100 to      where         to chickens             
                      200.            immunity to   producing               
                                      coccidiosis   eggs for                
                                      is not        human                   
                                      desired;      consumption             
                                      prevention    . Feed for              
                                      of            7 to 14 d.              
                                      coccidiosis                           
                                      ; control                             
                                      of                                    
                                      infectious                            
                                      synovitis                             
                                      caused by                             
                                      Mycoplasma                            
                                      synoviae                              
                                      susceptible                           
                                      to                                    
                                      chlortetrac                           
                                      ycline.                               
                     Chlortetracycl  For chickens  In low                   
                      ine 200 to      where         calcium                 
                      400.            immunity to   feed                    
                                      coccidiosis   containing              
                                      is not        0.8%                    
                                      desired;      dietary                 
                                      prevention    calcium and             
                                      of            1.5% sodium             
                                      coccidiosis   sulfate;                
                                      ; control     feed                    
                                      of chronic    continuousl             
                                      respiratory   y as sole               
                                      disease       ration for              
                                      (CRD) and     7 to 14 d;              
                                      air sac       do not feed             
                                      infection     to chickens             
                                      caused by     producing               
                                      M.            eggs for                
                                      galliseptic   human                   
                                      um and E.     consumption             
                                      coli          .                       
                                      susceptible                           
                                      to                                    
                                      chlortetrac                           
                                      ycline.                               
      *                    *                    *                    *      
                       *                    *                    *          
    ------------------------------------------------------------------------
    
        6. Section 558.128 is amended by revising paragraphs (a), (b), and 
    (c)(1); by removing paragraphs (c)(2) and (c)(3); and by redesignating 
    paragraphs (c)(4) and (c)(5) as paragraphs (c)(2) and (c)(3), to read 
    as follows:
    
    
    Sec. 558.128   Chlortetracycline.
    
        (a) Approvals. Type A medicated articles containing the following 
    concentrations of either chlortetracycline calcium complex equivalent 
    to chlortetracycline hydrochloride or, for products intended for use in 
    milk replacer, chlortetracycline hydrochloride:
        (1) 50 to 100 grams per pound to 000004 in Sec. 510.600(c) of this 
    chapter.
        (2) 50 to 100 grams per pound to 000069.
        (3) 50 to 100 grams per pound to 046573.
        (4) 50 grams per pound to 012286.
        (5) 50 to 100 grams per pound to 053389 .
        (b) Related tolerances. See Sec. 556.150 of this chapter.
        (c)(1) It is used in feeds as follows:
    
                                                                                                                    
    ----------------------------------------------------------------------------------------------------------------
      Chlortetracycline amount        Combination         Indications for use          Limitations         Sponsor  
    ----------------------------------------------------------------------------------------------------------------
    (i) 10 to 50 g/ton                                   1. Chickens; increased  Do not feed to              000004,
                                                         rate of weight gain      chickens producing         000069,
                                                         and improved feed        eggs for human             012286,
                                                         efficiency.              consumption.               046573,
                                                                                                              053389
                                                        2. Growing turkeys;      Do not feed to turkeys           do
                                                         increased rate of        producing eggs for                
                                                         weight gain and          human consumption.                
                                                         improved feed                                              
                                                         efficiency.                                                
                                                        3. Growing swine;                                         do
                                                         increased rate of                                          
                                                         weight gain and                                            
                                                         improved feed                                              
                                                         efficiency.                                                
    (ii) 20 to 50 g/ton                                 Growing sheep;                                       000004,
                                                         increased rate of                                   000069,
                                                         weight gain and                                     046573,
                                                         improved feed                                       053389.
                                                         efficiency.                                                
                                                                                                                    
    (iii) 50 to 100 g/ton                               Swine; reducing the                                  000004,
                                                         incidence of cervical                               000069,
                                                         lymphadenitis (jowl                                 012286,
                                                         abscesses) caused by                                046573,
                                                         Group E. Streptococci                                053389
                                                         susceptible to                                             
                                                         chlortetracycline.                                         
    (iv) 100 to 200 g/ton                               Chickens; control of     Feed continuously for            do
                                                         infectious synovitis     7 to 14 d; do not                 
                                                         caused by Mycoplasma     feed to chickens                  
                                                         synoviae susceptible     producing eggs for                
                                                         to chlortetracycline.    human consumption.                
    
    [[Page 35953]]
    
                                                                                                                    
    (v) 200 g/ton                                       Turkeys; control of      Feed continuously for            do
                                                         infectious synovitis     7 to 14 d; do not                 
                                                         caused by M. synoviae    feed to turkeys                   
                                                         susceptible to           producing eggs for                
                                                         chlortetracycline.       human consumption.                
    (vi) 200 to 400 g/ton                               1. Chickens; control of  Feed continuously for            do
                                                         chronic respiratory      7 to 14 d; do not                 
                                                         disease (CRD) and air    feed to chickens                  
                                                         sac infection caused     producing eggs for                
                                                         by M. gallisepticum      human consumption.                
                                                         and E. coli                                                
                                                         susceptible to                                             
                                                         chlortetracycline.                                         
                                                        2. Ducks; control and    Feed in complete             000004
                                                         treatment of fowl        ration to provide                 
                                                         cholera caused by        from 8 to 28                      
                                                         Pasteurella multocida    milligrams per pound              
                                                         susceptible to           of body weight per                
                                                         chlortetracycline.       day depending upon                
                                                                                  age and severity of               
                                                                                  disease, for not more             
                                                                                  than 21 d.                        
    (vii) 400 g/ton                                     1. Turkeys; control of   Feed continuously for       000004,
                                                         hexamitiasis caused by   7 to 14 d; do not          000069,
                                                         Hexamita meleagrides     feed to turkeys            012286,
                                                         susceptible to           producing eggs for         046573,
                                                         chlortetracycline.       human consumption.          053389
                                                        2. Turkey poults not                                      do
                                                         over 4 weeks of age;                                       
                                                         reduction of mortality                                     
                                                         due to paratyphoid                                         
                                                         caused by Salmonella                                       
                                                         typhimurium                                                
                                                         susceptible to                                             
                                                         chlortetracycline.                                         
                                                        3. Breeding swine;       Feed continuously for            do
                                                         control of               not more than 14 d.               
                                                         leptospirosis                                              
                                                         (reducing the                                              
                                                         incidence of abortion                                      
                                                         and shedding of                                            
                                                         leptospirae) caused by                                     
                                                         Leptospira pomona                                          
                                                         susceptible to                                             
                                                         chlortetracycline.                                         
    (viii) 500 g/ton                                    Chickens; reduction of   Feed for 5 d; do not             do
                                                         mortality due to E.      feed to chickens                  
                                                         coli infections          producing eggs for                
                                                         susceptible to           human consumption;                
                                                         chlortetracycline.       withdraw 24 h prior               
                                                                                  to slaughter.                     
    (ix)10 mg/g of finished                             Psittacine birds         Feed continuously for         00004
     feed daily.                                         (cockatoos, macaws,      45 d; each bird                   
                                                         and parrots) suspected   should consume daily              
                                                         or known to be           an amount of                      
                                                         infected with            medicated feed equal              
                                                         psittacosis caused by    to one fifth of its               
                                                         Chlamydia psittaci       body weight. Warning:             
                                                         sensitive to             ``Psittacosis, avian              
                                                         chlortetracycline.       chlamydiosis, or                  
                                                                                  ornithosis is a                   
                                                                                  reportable                        
                                                                                  communicable disease,             
                                                                                  transmissible between             
                                                                                  wild and domestic                 
                                                                                  birds, other animals,             
                                                                                  and man. Contact                  
                                                                                  appropriate public                
                                                                                  health and regulatory             
                                                                                  officials.''                      
    (x) 0.1 mg/lb of body                               Calves (up to 250 lb);   In milk replacers or        000004,
     weight daily.                                       for increased rate of    starter feed; include      000069,
                                                         weight gain and          on labeling the            012286,
                                                         improved feed            warning: ``A               046573,
                                                         efficiency.              withdrawal period has       053389
                                                                                  not been established              
                                                                                  for this product in               
                                                                                  pre-ruminating                    
                                                                                  calves. Do not use in             
                                                                                  calves to be                      
                                                                                  processed for veal.''             
    (xi) 0.5 mg/lb of body                              Beef cattle (over 700    Withdraw 48 h prior to           do
     weight daily.                                       lb); control of active   slaughter.                        
                                                         infection of                                               
                                                         anaplasmosis caused by                                     
                                                         Anaplasma marginale                                        
                                                         susceptible to                                             
                                                         chlortetracycline.                                         
    (xii) 10 mg/lb of body                              1. Calves, beef and      Treat for not more               do
     weight                                              nonlactating dairy       than 5 d; in feed                 
                                                         cattle; treatment of     excluding milk                    
                                                         bacterial enteritis      replacers; withdraw               
                                                         caused by E. coli and    10 d prior to                     
                                                         bacterial pneumonia      slaughter except for              
                                                         caused by P. multocida   24 h for sponsor                  
                                                         organisms susceptible    046573; include on                
                                                         to chlortetracycline.    labeling the warning:             
                                                                                  ``A withdrawal period             
                                                                                  has not been                      
                                                                                  established for this              
                                                                                  product in pre-                   
                                                                                  ruminating calves. Do             
                                                                                  not use in calves to              
                                                                                  be processed for                  
                                                                                  veal.''                           
    
    [[Page 35954]]
    
                                                                                                                    
                                                        2. Calves (up to 250     In milk replacers or               
                                                         lb); treatment of        starter feed; include             
                                                         bacterial enteritis      on labeling the                   
                                                         caused by E. coli        warning: ``A                      
                                                         susceptible to           withdrawal period has             
                                                         chlortetracycline.       not been established              
                                                                                  for this product in               
                                                                                  pre-ruminating                    
                                                                                  calves. Do not use in             
                                                                                  calves to be                      
                                                                                  processed for veal.''             
                                                        3. Swine; treatment of   Feed for not more than      000004,
                                                         bacterial enteritis      14 d; withdraw 5 d         000069,
                                                         caused by E. coli and    prior to slaughter         012286,
                                                         S. choleraesuis and      for sponsor 012286.        046573,
                                                         bacterial pneumonia                                  053389
                                                         caused by P. multocida                                     
                                                         susceptible to                                             
                                                         chlortetracycline.                                         
    (xiii) 25 mg/lb of body                             Turkeys; control of      Feed continuously for            do
     weight                                              complicating bacterial   7 to 14 d; do not                 
                                                         organisms associated     feed to turkeys                   
                                                         with bluecomb            producing eggs for                
                                                         (transmissible           human consumption.                
                                                         enteritis; coronaviral                                     
                                                         enteritis) susceptible                                     
                                                         to chlortetracycline.                                      
    (xiv) 25 to 70 mg/head/day                          Calves (250 to 400 lb);  Include on labeling         000004,
                                                         increased rate of        the warning: ``A           000069,
                                                         weight gain and          withdrawal period has      012286,
                                                         improved feed            not been established       046573,
                                                         efficiency.              for this product in         053389
                                                                                  pre-ruminating                    
                                                                                  calves. Do not use in             
                                                                                  calves to be                      
                                                                                  processed for veal.''             
    (xv) 70 mg/head/day                                 Growing cattle (over     do                               do
                                                         400 lb) increased rate                                     
                                                         of weight gain,                                            
                                                         improved feed                                              
                                                         efficiency, and                                            
                                                         reduction of liver                                         
                                                         condemnation due to                                        
                                                         liver abscesses.                                           
    (xvi) 80 mg/head/day                                Breeding sheep;                                      000004,
                                                         reducing the incidence                              000069,
                                                         of (vibrionic)                                      046573,
                                                         abortion caused by                                   053389
                                                         Campylobacter fetus                                        
                                                         infection susceptible                                      
                                                         to chlortetracycline.                                      
    (xvii) 350 mg/head/day                              1. Cattle (under 700     Withdraw 48 h prior to      000004,
                                                         lb); control of          slaughter.                 000069,
                                                         bacterial pneumonia                                 012286,
                                                         associated with                                     046573,
                                                         shipping fever complex                               053389
                                                         caused by Pasteurella                                      
                                                         spp. susceptible to                                        
                                                         chlortetracycline.                                         
                                                        2. Beef cattle (under    do                               do
                                                         700 lb); control of                                        
                                                         active infection of                                        
                                                         anaplasmosis caused by                                     
                                                         A. marginale                                               
                                                         susceptible to                                             
                                                         chlortetracycline.                                         
    ----------------------------------------------------------------------------------------------------------------
    
    
    
    * * * * *
        7. New Sec. 558.140 is added to subpart B to read as follows:
    
    
    Sec. 558.140   Chlortetracycline and sulfamethazine.
    
        (a) Approvals. Type A medicated articles: 35 grams of 
    chlortetracycline per pound with 7.7 percent (35 grams) of 
    sulfamethazine to 000004 in Sec. 510.600(c) of this chapter.
        (b) Related tolerances. See Secs. 556.150 and 556.670 of this 
    chapter.
        (c) It is used in feed for beef cattle as follows:
        (1) Amount per head per day. Chlortetracycline, 350 milligrams plus 
    sulfamethazine, 350 milligrams.
        (2) Indications for use. Aid in the maintenance of weight gains in 
    the presence of respiratory disease such as shipping fever.
        (3) Limitations. Feed for 28 days; withdraw 7 days prior to 
    slaughter.
        8. Section 558.175 is amended by revising paragraph (c)(2)(ii) to 
    read as follows:
    
    
    Sec. 558.175   Clopidol.
    
    * * * * *
        (c) * * *
        (2) * * *
        (ii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus 
    chlortetracycline 100 to 200 grams.
        (a) Indications for use. Aid in the prevention of coccidiosis 
    caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. 
    brunetti, and E. mivati; control of infectious synovitis caused by 
    Mycoplasma synoviae susceptible to chlortetracycline.
        (b) Limitations. Feed continuously as sole ration from the time 
    chicks are placed in floor pens for 7 to 14 days.
    * * * * *
        9. Section 558.195 is amended in the table in paragraph (d) in the 
    entry for ``27.2 (0.003pct)'' by removing the item for 
    ``Chlortetracycline 200'' and adding in its place an item for 
    ``Chlortetracycline 100 to 200'' and an item for ``Chlortetracycline 
    200 and 400'' to read as follow:
    
    
    Sec. 558.195   Decoquinate.
    
    * * * * *
        (d) *  *  *
    
    [[Page 35955]]
    
    
    
                                                                            
    ------------------------------------------------------------------------
                     Combination                                            
    Decoquinate in   in grams per   Indications    Limitations     Sponsor  
     grams per ton       ton          for use                               
    ------------------------------------------------------------------------
    27.2                                                                    
     (0.003pct)                                                             
      *                    *                    *                    *      
                       *                    *                    *          
                    Chlortetracyc  Chickens; for  Do not feed         011526
                     line 100 to    the            to chickens              
                     200.           prevention     producing                
                                    of             eggs for                 
                                    coccidiosis    human                    
                                    caused by      consumption;             
                                    Eimeria        in low                   
                                    tenella, E.    calcium feed             
                                    necatrix, E.   containing               
                                    mivati, E.     0.8 pct. of              
                                    acervulina,    calcium;                 
                                    E. maxima,     feed                     
                                    and E.         continuously             
                                    brunetti;      7 to 14                  
                                    control of     days.                    
                                    infectious                              
                                    synovitis                               
                                    caused by                               
                                    Mycoplasma                              
                                    synoviae                                
                                    susceptible                             
                                    to                                      
                                    chlortetracy                            
                                    cline.                                  
                    Chlortetracyc  Chickens; for  do                  011526
                     line 200 to    the                                     
                     400.           prevention                              
                                    of                                      
                                    coccidiosis                             
                                    caused by E.                            
                                    tenella, E.                             
                                    necatrix, E.                            
                                    mivati , E.                             
                                    acervulina,                             
                                    E. maxima,                              
                                    and E.                                  
                                    brunetti;                               
                                    control of                              
                                    chronic                                 
                                    respiratory                             
                                    disease                                 
                                    (CRD) and                               
                                    air sac                                 
                                    infection                               
                                    caused by M.                            
                                    gallisepticu                            
                                    m and E.                                
                                    coli                                    
                                    susceptible                             
                                    to                                      
                                    chlortetracy                            
                                    cline.                                  
      *                    *                    *                    *      
                       *                    *                    *          
    ------------------------------------------------------------------------
    
        10. Section 558.274 is amended in the table in paragraph (c)(1) 
    under entry (i) by revising the item for ``Chlortetracycline 100 to 
    200'' and by adding a new item for ``Chlortetracycline 200 to 400''; 
    and under entry (ii) by removing the item for ``Chlortetracycline 100 
    to 200'' and adding in its place an item for ``Chlortetracycline 400'' 
    to read as follows:
    
    
    Sec. 558.274  Hygromycin B.
    
    * * * * *
        (c) * * *
        (1) * * *
    
                                                                            
    ------------------------------------------------------------------------
     Hygromycin B    Combination                                            
     in grams per    in grams per   Indications    Limitations     Sponsor  
          ton            ton          for use                               
    ------------------------------------------------------------------------
    (i) * * *                                                               
      *                    *                    *                    *      
                       *                    *                    *          
                    Chlortetracyc  Chickens;      Do not feed               
                     line 100 to    control of     to chickens              
                     200.           infestation    producing                
                                    of large       eggs for                 
                                    roundworms     human                    
                                    (Ascaris       consumption;             
                                    galli),        feed for 7               
                                    cecal worms    to 14 days;              
                                    (Heterakis     withdraw 3               
                                    gallinae),     days before              
                                    and            slaughter.               
                                    capillary                               
                                    worms                                   
                                    (Capillaria                             
                                    obsignata);                             
                                    control of                              
                                    infectious                              
                                    synovitis                               
                                    caused by                               
                                    Mycoplasma                              
                                    synoviae                                
                                    susceptible                             
                                    to                                      
                                    chlortetracy                            
                                    cline.                                  
                    Chlortetracyc  Chickens;      do                        
                     line 200 to    control of                              
                     400.           infestation                             
                                    of large                                
                                    roundworms                              
                                    (Ascaris                                
                                    galli),                                 
                                    cecal worms                             
                                    (H.                                     
                                    Gallinae),                              
                                    and                                     
                                    capillary                               
                                    worms                                   
                                    (Capillaria                             
                                    obsignata);                             
                                    control of                              
                                    chronic                                 
                                    respiratory                             
                                    disease                                 
                                    (CRD) and                               
                                    air sac                                 
                                    infection                               
                                    caused by                               
                                    Mycoplasma                              
                                    gallisepticu                            
                                    m and                                   
                                    Escherichia                             
                                    coli                                    
                                    susceptible                             
                                    to                                      
                                    chlortetracy                            
                                    cline.                                  
      *                    *                    *                    *      
                       *                    *                    *          
    (ii) * * *                                                              
    
    [[Page 35956]]
    
                                                                            
      *                    *                    *                    *      
                       *                    *                    *          
                    Chlortetracyc  Swine;         Withdraw 15 d             
                     line 400.      control of     before                   
                                    infestation    slaughter.               
                                    of large                                
                                    roundworms                              
                                    (Ascaris                                
                                    suis),                                  
                                    nodular                                 
                                    worms                                   
                                    (Oesophagost                            
                                    omum                                    
                                    dentatum)                               
                                    and                                     
                                    whipworms                               
                                    (Trichuris                              
                                    suis);                                  
                                    treatment of                            
                                    bacterial                               
                                    enteritis                               
                                    caused by E.                            
                                    coli and                                
                                    Salmonella                              
                                    choleraesuis                            
                                    and                                     
                                    bacterial                               
                                    pneumonia                               
                                    caused by P.                            
                                    multocida                               
                                    susceptible                             
                                    to                                      
                                    chlortetracy                            
                                    cline.                                  
      *                    *                    *                    *      
                       *                    *                    *          
    ------------------------------------------------------------------------
    
    
    * * * * *
        11. Section 558.515 is amended by revising paragraphs (d)(1)(iii), 
    (d)(1)(iv), and (d)(1)(v)(b) to read as follows:
    
    
    Sec. 558.515  Robenidine hydrochloride.
    
    * * * * *
        (d) * * *
        (1) * * *
        (iii) Amount per ton. Robenidine hydrochloride, 30 grams (0.0033 
    percent) plus chlortetracycline, 100 to 200 grams.
        (a) Indications for use. As an aid in the prevention of coccidiosis 
    caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, 
    and E. necatrix; control of infectious synovitis caused by Mycoplasma 
    synoviae susceptible to chlortetracycline.
        (b) Limitations. Withdraw 5 days prior to slaughter; do not feed to 
    chickens producing eggs for human consumption; feed continuously as 
    sole ration up to 14 days.
        (iv) Amount per ton. Robenidine hydrochloride, 30 grams (0.0033 
    percent) plus chlortetracycline, 200 to 400 grams.
        (a) Indications for use. As an aid in the prevention of coccidiosis 
    caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, 
    and E. necatrix; control of chronic respiratory disease (CRD) and air 
    sac infection caused by M. gallisepticum and E. coli susceptible to 
    chlortetracycline.
        (b) Limitations. Withdraw 5 days prior to slaughter; do not feed to 
    chickens producing eggs for human consumption; feed continuously as 
    sole ration up to 14 days.
        (v) * * *
        (b) Limitations. Withdraw 5 days prior to slaughter; do not feed to 
    chickens producing eggs for human consumption; feed continuously up to 
    5 days.
     * * * * *
        12. Section 558.530 is amended by revising paragraph (a); by 
    redesignating paragraphs (d)(2), (d)(3), and (d)(4) as paragraphs 
    (d)(4), (d)(5), and (d)(6), by adding new paragraphs (d)(2) and (d)(3); 
    and by revising newly redesignated paragraph (d)(4) to read as set 
    forth below, and in newly redesignated paragraph (d)(6) by 
    redesignating paragraphs (d)(6)(i)(a) through (d) as paragraphs 
    (d)(6)(i)(A) through (D).:
    
    
    Sec. 558.530  Roxarsone.
    
        (a) Approvals. Type A medicated articles: (1) 10, 20, and 50 
    percent to 011526 in Sec. 510.600(c) of this chapter for use as in 
    paragraph (d)(1) of this section.
        (2) 10, 20, 50, and 80 percent to 046573 in Sec. 510.600(c) of this 
    chapter for use as in paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of 
    this section.
    * * * * *
        (d) * * *
        (2) Growing chickens--(i) Grams per ton. Roxarsone, 22.7 to 45.4 
    (0.0025 to 0.005 percent) plus chlortetracycline, 10 to 50.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation.
        (B) Limitations. Do not feed to chickens producing eggs for human 
    consumption; withdraw 5 days before slaughter; as sole source of 
    organic arsenic; drug overdose or lack of water may result in leg 
    weakness; feed continuously throughout growing period.
        (ii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 
    percent) plus chlortetracycline, 100 to 200.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation; control of 
    infectious synovitis caused by Mycoplasma synoviae susceptible to 
    chlortetracycline.
        (B) Limitations. See paragraph (d)(2)(i)(B) of this section except 
    feed continuously for 7 to 14 days.
        (iii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 
    percent) plus chlortetracycline, 200 to 400.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation; control of chronic 
    respiratory disease (CRD) and air sac infection caused by M. 
    gallisepticum and Escherichia coli susceptible to chlortetracycline.
        (B) Limitations. See paragraph (d)(2)(i)(B) of this section except 
    feed continuously for 7 to 14 days.
        (iv) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 
    percent) plus chlortetracycline, 500.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation; reduction of 
    mortality due to E. coli infections susceptible to chlortetracycline.
        (B) Limitations. See paragraph (d)(2)(i)(B) of this section except 
    feed for 5 days.
        (3) Growing turkeys--(i) Grams per ton. Roxarsone 22.7 to 45.4 
    (0.0025 to 0.005 percent) plus chlortetracycline, 10 to 50.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation.
        (B) Limitations. Do not feed to turkeys producing eggs for human 
    consumption; withdraw 5 days before slaughter; as sole source of 
    organic arsenic; drug overdose or lack of water may result in leg 
    weakness; feed continuously throughout growing season.
        (ii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 
    percent) plus chlortetracycline 200.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation; control of 
    infectious synovitis caused by
    
    [[Page 35957]]
    
    M. synoviae susceptible to chlortetracycline.
        (B) Limitations. See paragraph (d)(3)(i)(B) of this section except 
    that the drug should only be fed continuously for 7 to 14 days.
        (iii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 
    percent) plus chlortetracycline, 400.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation; control of 
    hexamitiasis caused by Hexamita meleagrides susceptible to 
    chlortetracycline. Turkey poults not over 4 weeks of age: Reduction of 
    mortality due to paratyphoid caused by Salmonella typhimurium 
    susceptible to chlortetracycline.
        (B) Limitations. See paragraph (d)(3)(i)(B) of this section except 
    that the drug should only be fed continuously for 7 to 14 days.
        (iv) Amount. Roxarsone 22.7 to 45.4 grams per ton (0.0025 to 0.005 
    percent) plus chlortetracycline, 25 milligrams per pound of body weight 
    daily.
        (A) Indications for use. For increased rate of weight gain, 
    improved feed efficiency, and improved pigmentation; control of 
    complicating bacterial organisms associated with bluecomb 
    (transmissible enteritis, coronaviral enteritis) susceptible to 
    chlortetracycline.
        (B) Limitations. See paragraph (d)(3)(i)(B) of this section except 
    that the drug should only be fed continuously for 7 to 14 days.
        (4) Growing-finishing swine--(i) Grams per ton. Roxarsone 22.7 to 
    34.1 (0.0025 to 0.00375 percent).
        (A) Indications for use. For increased rate of weight gain and 
    improved feed efficiency.
        (B) Limitations. Withdraw 5 days before slaughter; as sole source 
    of organic arsenic; feed continuously throughout growing season.
        (ii) Grams per ton. Roxarsone 22.7 to 34.1 (0.0025 to 0.00375 
    percent) plus chlortetracycline, 400 (to administer 10 milligrams per 
    pound of body weight).
        (A) Indications for use. For increased rate of weight gain and 
    improved feed efficiency; treatment of bacterial enteritis caused by E. 
    coli and S. choleraesuis and bacterial pneumonia caused by P. multocida 
    susceptible to chlortetracycline.
        (B) Limitations. Withdraw 5 days before slaughter; as sole source 
    of organic arsenic; feed for not more than 14 days.
        (iii) Grams per ton. Roxarsone 181.5 (0.02 percent).
        (A) Indications for use. For the treatment of swine dysentery.
        (B) Limitations. Feed for not more than 6 consecutive days; if 
    improvement is not observed, consult a veterinarian; withdraw 5 days 
    before slaughter; as a sole source or organic arsenic; animals must 
    consume enough medicated feed to provide a therapeutic dose.
        (iv) Grams per ton. Roxarsone, 181.5 (0.02 percent) plus 
    chlortetracycline, 10 to 50.
        (A) Indications for use. For the treatment of swine dysentery; 
    increased rate of weight gain and improved feed efficiency.
        (B) Limitations. See paragraph (d)(4)(iii)(B) of this section.
        (v) Grams per ton. Roxarsone, 181.5 (0.02 percent) plus 
    chlortetracycline, 400.
        (A) Indications for use. For the treatment of swine dysentery; 
    treatment of bacterial enteritis caused by E. coli and S. choleraesuis 
    and bacterial pneumonia caused by P. multocida susceptible to 
    chlortetracycline.
        (B) Limitations. See paragraph (d)(4)(iii)(B) of this section.
    * * * * *
        13. Section 558.680 is amended in the table in paragraph (c)(1) 
    under entries (i) and (ii) by revising the item for ``Chlortetracycline 
    100 to 200''; by removing the item for ``Chlortetracycline 200'' and 
    adding in its place an item for ``Chlortetracycline 200 to 400'' to 
    read as follows:
    
    
    Sec. 558.680  Zoalene.
    
    * * * * *
        (c) * * *
        (1) * * *
    
                                                                            
    ------------------------------------------------------------------------
       Zoalene in     Combination in    Indications for                     
       grams/ton        grams/ton             use             Limitations   
    ------------------------------------------------------------------------
    (i) * * *                                                               
      *                    *                    *                    *      
                       *                    *                    *          
                     Chlortetracycli  Replacement         Do not feed to    
                      ne 100 to 200.   chickens;           chickens         
                                       development of      producing eggs   
                                       active immunity     for human        
                                       to coccidiosis;     consumption;     
                                       control of          grower ration not
                                       infectious          to be fed to     
                                       synovitis caused    birds over 14    
                                       by Mycoplasma       weeks of age;    
                                       synoviae            feed as in       
                                       susceptible to      subtable in item 
                                       chlortetracycline   (i).             
                                       .                                    
                     Chlortetracycli  Replacement         Do not feed to    
                      ne 200 to 400.   chickens;           chickens         
                                       development of      producing eggs   
                                       active immunity     for human        
                                       to coccidiosis;     consumption;     
                                       control of          grower ration not
                                       chronic             to be fed to     
                                       respiratory         birds over 14    
                                       disease (CRD) and   weeks of age;    
                                       air sac infection   feed as in       
                                       caused by M.        subtable in item 
                                       gallisepticum and   (i).             
                                       Escherichia coli                     
                                       susceptible to                       
                                       chlortetracycline                    
                                       .                                    
      *                    *                    *                    *      
                       *                    *                    *          
    (ii) * * *                                                              
      *                    *                    *                    *      
                       *                    *                    *          
                     Chlortetracycli  Broiler chickens;   Do not feed to    
                      ne 100 to 200    prevention and      chickens         
                                       control of          producing eggs   
                                       coccidiosis;        for human        
                                       control of          consumption; feed
                                       infectious          continuously for 
                                       synovitis caused    7 to 14 d.       
                                       by M. synoviae                       
                                       susceptible to                       
                                       chlortetracycline                    
                                       .                                    
    
    [[Page 35958]]
    
                                                                            
                     Chlortetracycli  Broiler chickens;   Do not feed to    
                      ne 200 to 400    prevention and      chickens         
                                       control of          producing eggs   
                                       coccidiosis;        for human        
                                       control of          consumption; feed
                                       chronic             continuously for 
                                       respiratory         7 to 14 d.       
                                       disease (CRD) and                    
                                       air sac infection                    
                                       caused by M.                         
                                       gallisepticum and                    
                                       E. coli                              
                                       susceptible to                       
                                       chlortetracycline                    
                                       .                                    
      *                    *                    *                    *      
                       *                    *                    *          
    ------------------------------------------------------------------------
    
    
    * * * * *
    
        Dated: June 13, 1996.
    Andrew J. Beaulieau,
    Acting Director, Office of New Animal Drug Evaluation, Center for 
    Veterinary Medicine.
    [FR Doc. 96-17169 Filed 7-8-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
7/9/1996
Published:
07/09/1996
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-17169
Dates:
July 9, 1996.
Pages:
35949-35958 (10 pages)
PDF File:
96-17169.pdf
CFR: (11)
21 CFR 510.515
21 CFR 558.55
21 CFR 558.58
21 CFR 558.128
21 CFR 558.140
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