[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51588-51593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25257]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Oxytetracycline Type A 
Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
revised labeling for Pfizer's pioneer, Type A, oxytetracycline-
containing, medicated articles which brings the products into 
compliance with the findings of the National Academy of Sciences/
National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI) 
effectiveness evaluation and subsequent FDA conclusions. In addition, 
the regulations are further amended to reflect approval, based on FDA's 
DESI ``me-too'' policy, of one original NADA each filed by Pfizer and 
PennField Oil Co. for Type A medicated articles that are copies of the 
Pfizer pioneer products.

EFFECTIVE DATE: October 3, 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: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed a supplement to its approved NADA 8-804 which covers the 
Type A medicated articles bearing the Terramycin 
(oxytetracycline (OTC)) trade name on their labels. The articles 
contain OTC quaternary salt expressed in terms of an equivalent amount 
of OTC hydrochloride (HCl) (i.e., Terramycin 10, 20, 50, 50D, 
100, 100D, 100SS, and 200). Pfizer also filed original NADA 95-143 
which covers the Type A medicated articles OXTC 10, 30, 50, 
50-S, 100, 100-S, 100MR, and 200. These articles contain OTC dihydrate 
base expressed in terms of an equivalent amount of OTC HCl. PennField 
Oil Co., 14040 Industrial Rd., Omaha, NE 68137, filed original NADA 
138-938 which covers the Type A medicated articles Oxytetracycline 50, 
100, and 100 MR (formulated for use in calf milk replacers or starter 
feeds). These articles also contain OTC quaternary salt expressed in 
terms of an equivalent amount of OTC HCl.
    Pfizer Type A medicated articles covered by NADA 8-804 were the 
subject of a NAS/NRC DESI evaluation of effectiveness (DESI 8622V). The 
findings were published in the Federal Register of May 5, 1970 (35 FR 
7089). NAS/NRC evaluated the articles as probably effective when used 
for the control and treatment of specific diseases of livestock (swine, 
cattle, sheep, rabbits, and mink) and poultry (broiler chickens, laying 
chickens, and turkeys), and concluded that use may result in faster 
gains and improved feed efficiency under appropriate conditions. NAS/
NRC stated that:
    1. Labels and package inserts require extensive revision. There is 
inadequate documentation of claims, excessive claims are made, and bold 
conclusions are reached in the absence of sufficient controlled 
experimental evidence.
    2. Claims for growth promotion or stimulation are not allowed 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) and if the disease cannot be so qualified the claim must be 
dropped.''
    4. The label claims ``for prevention of'' or ``to prevent'' should 
be replaced with ``as an aid in the control of'' or ``to aid in the 
control of.''
    5. The label claim pertaining to egg production and hatchability 
should be modified to read, ``May aid in maintaining egg production and

[[Page 51589]]

hatchability, under appropriate conditions, by controlling pathogenic 
organisms.''
    6. The labels should carry a warning that treated animals under the 
conditions that prevail must actually consume sufficient medicated 
water, or medicated feed, to constitute a therapeutic dose. As a 
precaution, the labels should state what the desired oral dose is in 
terms of animal weight per day for each species to serve as a guide to 
effective use of the preparations in drinking water or feed.
    7. The labels should declare the dosage for the treatment of 
individual animals in terms of the amount of drug which should be given 
per unit of animal weight.
    The ``probably effective'' finding of NAS/NRC was subsequently 
reviewed by FDA, resulting in an upgrade to ``effective'' status for 
the control and treatment of bacterial diseases susceptible to OTC in 
poultry, cattle, swine, sheep, and bees. FDA also made the following 
conclusions:
    1. The claims for hexamitiasis should be included under the 
susceptible host.
    2. Appropriate claims regarding faster weight gains and improved 
feed efficiency should be stated as ``For increased rate of weight gain 
and improved feed efficiency (under appropriate conditions of use).''
    Pfizer filed a supplement to NADA 8-804 that revised the labeling 
of its products to comply with the findings of the NAS/NRC review and 
FDA's conclusions concerning those findings. Pfizer's supplement to 
NADA 8-804 also provides for transfer to 8-804 of its proprietary 
claims previously approved, under NADA 38-439, for use of OTC in 
lobster, catfish, Pacific salmon, and salmonids. The supplemental NADA 
is approved as of March 14, 1996.
    The Type A medicated articles covered by Pfizer's NADA 95-143 
(containing OTC dihydrate base) and those covered by PennField's NADA 
138-938 (containing OTC quaternary salt) have demonstrated 
comparability to Pfizer's pioneer products (NADA 8-804, 
Terramycin Premixes containing OTC quaternary salt equivalent 
in activity to a concentration of OTC HCl declared in grams per pound 
of premix) which were subject to the NAS/NRC evaluation of May 5, 1970. 
Based on that comparability, original NADA's 95-143 and 138-938 are 
approved as of May 30, 1996, and March 15, 1996, respectively, under 
FDA's DESI ``me-too'' policy.
    FDA has now completed the NAS/NRC DESI evaluation for OTC Type A 
articles. Accordingly, FDA is revising Sec. 558.450 Oxytetracycline (21 
CFR 558.450) to set out the NAS/NRC and FDA-approved conditions of use 
for OTC articles. FDA also has replaced the claims for OTC articles 
listed in Sec. 558.15(g)(1) (21 CFR 558.15(g)(1)) with a cross-
reference to Sec. 558.450. This change makes the Sec. 558.15(g)(1) 
reference to OTC Type A articles the same as that for chlortetracycline 
(CTC) which cross-refers to Sec. 558.128 (21 CFR 558.128), the DESI-
finalized claims for that product (see the Federal Register of July 9, 
1996, 61 FR 35949).
    The NAS/NRC DESI evaluation is concerned only with the drugs' 
effectiveness and safety to the 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.
    Products that 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 obtain 
approval of abbreviated new animal drug applications (ANADA's) for 
these OTC Type A medicated articles.
    Also, the agency is revising Sec. 558.515(d)(2) (21 CFR 
558.515(d)(2)) to make the claim language for the robenidine/OTC 
combination consistent with the NAS/NRC DESI findings.
    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 OTC) 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 OTC 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 these applications 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)(ii) and (c)(2)(F)(iii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii) and 
(c)(2)(F)(iii)), these approvals for food-producing animals do not 
qualify for marketing exclusivity because the original and 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 
applicants.
    The agency has carefully considered the potential environmental 
effects of approving supplemental NADA 8-804. 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.
    The agency has determined under 21 CFR 25.24(d)(1)(i) that approval 
of original NADA's 95-143 and 138-938 is the type of action that does 
not individually or cumulatively have a significant effect on the human 
environment. Therefore, neither environmental assessments nor 
environmental impact statements are required.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec. 558.15  [Amended]

    2. Section 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in 
the feed of animals is amended in the

[[Page 51590]]

table, in paragraph (g)(1) to read as follows:
    a. In the entry for ``Pfizer, Inc., PennField Oil Co., VPO, Inc., 
and Purina Mills, Inc.'', by removing ``, VPO, Inc., and Purina Mills, 
Inc.'';
    b. Under the ``Species'' column of this entry, by removing 
``Chickens and turkeys.'' and adding in its place ``Sec. 558.450.'';
    c. All of the subentries for Pfizer, Inc., PennField Oil Co., 
represented by ``Do.'' are removed;
    d. The ``Pfizer, Inc.'' entry for oxytetracycline for sheep, 
including the three subentries represented by ``Do.'' are removed;
    e. The ``Pfizer, Inc.'' entry for oxytetracycline for chickens, 
including the first subentry represented by ``Do.'' is removed.
    3. Section 558.450 is revised to read as follows:


Sec. 558.450  Oxytetracycline.

    (a) Approvals. Type A medicated articles:
    (1) 10, 20, 30, 50, 100, and 200 grams per pound to 000069 in 
Sec. 510.600(c) of this chapter.
    (2) 50 and 100 grams per pound to 053389 in Sec. 510.600(c) of this 
chapter.
    (b) Special considerations. (1) In accordance with Sec. 558.5 
labeling shall bear the statement: ``FOR USE IN DRY ANIMAL FEED ONLY. 
NOT FOR USE IN LIQUID FEED SUPPLEMENTS.''
    (2) The articles in paragraph (a)(1) of this section contain an 
amount of mono-alkyl (C8-C18) trimethylammonium 
oxytetracycline expressed in terms of an equivalent amount of 
oxytetracycline hydrochloride or an amount of oxytetracycline dihydrate 
base expressed in terms of an equivalent amount of oxytetracycline 
hydrochloride.
    (3) The articles in paragraph (a)(2) of this section contain an 
amount of mono-alkyl (C8-C18) trimethylammonium 
oxytetracycline expressed in terms of an equivalent amount of 
oxytetracycline hydrochloride.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d)(1) Conditions of use. It is used in feed as follows:

                                                     Table 1                                                    
----------------------------------------------------------------------------------------------------------------
 Oxytetracycline amount         Combination          Indications for use          Limitations          Sponsor  
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20 grams per                             Sheep; increased rate                                 000069,
 ton (g/ton)                                        of weight gain and                                    053389
                                                    improved feed                                               
                                                    efficiency.                                                 
(ii) 10 to 50 g/ton                                1. Chickens; increased   Do not feed to chickens           do
                                                    rate of weight gain      producing eggs for                 
                                                    and improved feed        human consumption.                 
                                                    efficiency.                                                 
                                                   2. Growing turkeys;      Do not feed to turkeys            do
                                                    increased rate of        producing eggs for                 
                                                    weight and improved      human consumption.                 
                                                    feed efficiency.                                            
                                                   3. Swine; increased                                        do
                                                    rate of weight and                                          
                                                    improved feed                                               
                                                    efficiency.                                                 
(iii) 100 g/ton                                    Turkeys; control of      Feed continuously for 7           do
                                                    hexamitiasis caused by   to 14 days (d); do not             
                                                    Hexamita meleagridis     feed to turkeys                    
                                                    susceptible to           producing eggs for                 
                                                    oxytetracycline.         human consumption.                 
(iv) 100 to 200 g/ton                              Chickens; control of     Feed continuously for 7           do
                                                    infectious synovitis     to 14 d; do not feed               
                                                    caused by Mycoplasma     to chickens producing              
                                                    synoviae; control of     eggs for human                     
                                                    fowl cholera caused by   consumption; in low                
                                                    Pasteurella multocida    calcium feed, withdraw             
                                                    susceptible to           3 d before slaughter.              
                                                    oxytetracycline.                                            
                          Nequinate 18.16 g/ton    Chickens; control of     do                            000069
                           (0.002%)                 infectious synovitis                                        
                                                    caused by M. synoviae;                                      
                                                    control of fowl                                             
                                                    cholera caused by P.                                        
                                                    multocida susceptible                                       
                                                    to oxytetracycline; as                                      
                                                    an aid in the control                                       
                                                    of coccidiosis caused                                       
                                                    by Eimeria tenella, E.                                      
                                                    necatrix, E.                                                
                                                    acervulina, E. maxima,                                      
                                                    E. brunetti, and E.                                         
                                                    mivati.                                                     
(v) 200 g/ton                                      Turkeys; control of      Feed continuously for 7      000069,
                                                    infectious synovitis     to 14 d; withdraw 5 d        053389
                                                    caused by M. synoviae    before slaughter; do               
                                                    susceptible to           not feed to turkeys                
                                                    oxytetracycline.         producing eggs for                 
                                                                             human consumption.                 
(vi) 400 g/ton                                     Chickens; control of     Feed continuously for 7           do
                                                    chronic respiratory      to 14 d; do not feed               
                                                    disease (CRD) and air    to chickens producing              
                                                    sac infection caused     eggs for human                     
                                                    by M. gallisepticum      consumption; in low                
                                                    and Escherichia coli     calcium feeds,                     
                                                    susceptible to           withdraw 3 d before                
                                                    oxytetracycline.         slaughter.                         

[[Page 51591]]

                                                                                                                
                          Monensin 90 to 110 g/    Chickens; control of     do                            000069
                           ton                      CRD and air sac                                             
                                                    infection caused by M.                                      
                                                    gallisepticum and E.                                        
                                                    coli susceptible to                                         
                                                    oxytetracycline; and                                        
                                                    as an aid in the                                            
                                                    prevention of                                               
                                                    coccidiosis caused by                                       
                                                    E. necatrix, E.                                             
                                                    tenella, E.                                                 
                                                    acervulina, E.                                              
                                                    brunetti, E. mivati,                                        
                                                    and E. maxima.                                              
                          Nequinate 18.16 g/ton    Chickens; control of     do                                do
                           (0.002%)                 CRD and air sac                                             
                                                    infection caused by M.                                      
                                                    gallisepticum and E.                                        
                                                    coli susceptible to                                         
                                                    oxytetracycline; as an                                      
                                                    aid in prevention of                                        
                                                    coccidiosis caused by                                       
                                                    E. tenella, E.                                              
                                                    necatrix, E.                                                
                                                    acervulina, E. maxima,                                      
                                                    E. brunetti, and E.                                         
                                                    mivati.                                                     
(vii) 500 g/ton                                    Chickens; reduction of   Feed continuously for 5      000069,
                                                    mortality due to air     d; do not feed to            053389
                                                    sacculitis (air-sac-     chickens producing                 
                                                    infection) caused by     eggs for human                     
                                                    E. coli susceptible to   consumption; withdraw              
                                                    oxytetracycline.         24 hours before                    
                                                                             slaughter; in low                  
                                                                             calcium feeds withdraw             
                                                                             3 d before slaughter.              
                          Monensin 90 to 110 g/    Chickens; reduction of   do                            000069
                           ton                      mortality due to air                                        
                                                    sacculitis (air-sac-                                        
                                                    infection) caused by                                        
                                                    E. coli susceptible to                                      
                                                    oxytetracycline; as an                                      
                                                    aid in the prevention                                       
                                                    of coccidiosis caused                                       
                                                    by E. necatrix, E.                                          
                                                    tenella, E.                                                 
                                                    acervulina, E.                                              
                                                    brunetti, E. mivati,                                        
                                                    and E. maxima.                                              
                          Salinomycin 40 to 60 g/  Chickens; reduction of   do                           000069,
                           ton                      mortality due to air                                  012799
                                                    sacculitis (air-sac-                                        
                                                    infection) caused by                                        
                                                    E. coli susceptible to                                      
                                                    oxytetracycline;                                            
                                                    prevention of                                               
                                                    coccidiosis caused by                                       
                                                    E. necatrix, E.                                             
                                                    tenella, E.                                                 
                                                    acervulina, E.                                              
                                                    brunetti, E. mivati,                                        
                                                    and E. maxima.                                              
(viii) 0.05 to 0.1                                 Calves (up to 250 lb);   Feed continuously; in        000069,
 milligram/pound (mg/lb)                            for increased rate of    milk replacers or            053389
 of body weight daily.                              weight gain and          starter feed.                      
                                                    improved feed                                               
                                                    efficiency.                                                 
(ix) 10 mg/lb of body                              1.Calves and beef and    Feed continuously for 7           do
 weight daily.                                      nonlactating dairy       to 14 d; in feed or                
                                                    cattle; treatment of     milk replacers;                    
                                                    bacterial enteritis      withdraw 5 d before                
                                                    caused by E. coli and    slaughter.                         
                                                    bacterial pneumonia                                         
                                                    (shipping fever                                             
                                                    complex) caused by P.                                       
                                                    multocida susceptible                                       
                                                    to oxytetracycline.                                         
                                                   2. Calves (up to 250     Feed continuously for 7           do
                                                    lb); treatment of        to 14 d; in milk                   
                                                    bacterial enteritis      replacers or starter               
                                                    caused by E. coli        feed; withdraw 5 d                 
                                                    susceptible to           before slaughter.                  
                                                    oxytetracycline.                                            
                                                   3. Sheep; treatment of   Feed continuously for 7           do
                                                    bacterial enteritis      to 14 d; withdraw 5 d              
                                                    caused by E. coli and    before slaughter.                  
                                                    bacterial pneumonia                                         
                                                    caused by P. multocida                                      
                                                    susceptible to                                              
                                                    oxytetracycline.                                            

[[Page 51592]]

                                                                                                                
                                                   4. Swine; treatment of   Feed continuously for 7           do
                                                    bacterial enteritis      to 14 d; withdraw 5 d              
                                                    caused by E. coli and    before slaughter.                  
                                                    Salmonella                                                  
                                                    choleraesuis                                                
                                                    susceptible to                                              
                                                    oxytetracycline and                                         
                                                    treatment of bacterial                                      
                                                    pneumonia caused by P.                                      
                                                    multocida susceptible                                       
                                                    to oxytetracycline.                                         
                                                   5. Breeding swine;       Feed continuously for             do
                                                    control and treatment    not more than 14 d;                
                                                    of leptospirosis         withdraw 5 d before                
                                                    (reducing the            slaughter.                         
                                                    incidence of abortion                                       
                                                    and shedding of                                             
                                                    leptospirae) caused by                                      
                                                    Leptospira pomona                                           
                                                    susceptible to                                              
                                                    oxytetracycline.                                            
(x) 25 mg/lb of body                               Turkeys; control of      Feed continuously for 7           do
 weight                                             complicating bacterial   to 14 d; withdraw 5 d              
                                                    organisms associated     before slaughter; do               
                                                    with bluecomb            not feed to turkeys                
                                                    (transmissible           producing eggs for                 
                                                    enteritis; coronaviral   human consumption.                 
                                                    enteritis) susceptible                                      
                                                    to oxytetracycline.                                         
(xi) 25 mg/head/day                                Calves (250 to 400 lb);                                    do
                                                    increased rate of                                           
                                                    weight gain and                                             
                                                    improved feed                                               
                                                    efficiency.                                                 
(xii) 75 mg/head/day                               Growing cattle (over                                       do
                                                    400 lb); increased                                          
                                                    rate of weight gain;                                        
                                                    improved feed                                               
                                                    efficiency, and                                             
                                                    reduction of liver                                          
                                                    condemnation due to                                         
                                                    liver abscesses.                                            
(xiii) 0.5 to 2.0 g/head/                          Cattle; prevention and   Feed 3 to 5 d before              do
 day                                                treatment of the early   and after arrival in               
                                                    stages of shipping       feedlots.                          
                                                    fever complex.                                              
(xiv) 200 mg/colony                                Honey bees; control of   Remove at least 6 weeks           do
                                                    American foulbrood       prior to main honey                
                                                    caused by Bacillus       flow.                              
                                                    larvae and European                                         
                                                    foulbrood caused by                                         
                                                    Streptococcus pluton                                        
                                                    susceptible to                                              
                                                    oxytetracycline.                                            
----------------------------------------------------------------------------------------------------------------

    (2) It is used in fish feed as follows:

                                                     Table 2                                                    
----------------------------------------------------------------------------------------------------------------
 Oxytetracycline amount         Combination          Indications for use          Limitations          Sponsor  
----------------------------------------------------------------------------------------------------------------
(i) 250 mg/kilogram of                             Pacific salmon for       For salmon not over 30        000069
 fish/d (11.35 g/100 lb                             marking of skeletal      g body weight;                     
 of fish/d).                                        tissue.                  administer as sole                 
                                                                             ration for 4                       
                                                                             consecutive days in                
                                                                             feed containing                    
                                                                             oxytetracycline                    
                                                                             hydrochloride or mono-             
                                                                             alkyl (C8-C18)                     
                                                                             trimethyl ammonium                 
                                                                             oxytetracycline; fish              
                                                                             not to be liberated                
                                                                             for at least 7 d                   
                                                                             following the last                 
                                                                             administration of                  
                                                                             medicated feed.                    
(ii) 2.5 to 3.75 g/100                             1. Salmonids; control    Administer as mono-           000069
 lb of fish/d.                                      of ulcer disease         alkyl (C8-C18)                     
                                                    caused by Hemophilus     trimethyl ammonium                 
                                                    piscium, furunculosis    oxytetracycline in                 
                                                    caused by Aeromonas      mixed ration for 10 d;             
                                                    salmonicida, bacterial   do not liberate fish               
                                                    hemorrhagic septicemia   or slaughter fish for              
                                                    caused by A.             food for 21 d                      
                                                    liquefaciens, and        following the last                 
                                                    pseudomonas disease.     administration of                  
                                                                             medicated feed; do not             
                                                                             administer when water              
                                                                             temperature is below 9             
                                                                             C (48.2 F).                        

[[Page 51593]]

                                                                                                                
                                                   2. Catfish; control of   Administer as mono-           000069
                                                    bacterial hemorrhagic    alkyl (C8-C18)                     
                                                    septicemia caused by     trimethyl ammonium                 
                                                    A. liquefaciens and      oxytetracycline in                 
                                                    pseudomonas disease.     mixed ration for 10 d;             
                                                                             do not liberate fish               
                                                                             or slaughter fish for              
                                                                             food for 21 d                      
                                                                             following the last                 
                                                                             administration of                  
                                                                             medicated feed; do not             
                                                                             administer when water              
                                                                             temperature is below               
                                                                             16.7 C (62 F)                      
(iii) 1 g/lb of                                    Lobsters; control of     Administer as sole            000069
 medicated feed.                                    gaffkemia caused by      ration for 5                       
                                                    Aerococcus viridans.     consecutive days in                
                                                                             feed containing                    
                                                                             monoalkyl (C8-C18)                 
                                                                             trimethyl ammonium                 
                                                                             oxytetracycline;                   
                                                                             withdraw medicated                 
                                                                             feed 30 d before                   
                                                                             harvesting lobsters.               
----------------------------------------------------------------------------------------------------------------

    (3) Oxytetracycline may be used in accordance with the provisions 
of this section in the combinations provided as follows:
    (i) Robenidine hydrochloride in accordance with Sec. 558.515.
    (ii) Lasalocid as in Sec. 558.311.
    4. Section 558.515 is amended by revising paragraph (d)(2) to read 
as follows:


Sec. 558.515  Robenidine hydrochloride.

* * * * *
    (d) * * *
    (2) For broiler chickens--(i) Amount per ton. Robenidine 
hydrochloride, 30 grams (0.0033 percent) plus oxytetracycline, 400 
grams.
    (ii) Indications for use. As an aid in the prevention of 
coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. 
acervulina, E. maxima, and E. necatrix; control of CRD and air sac 
infection caused by Mycoplasma gallisepticum and Escherichia coli 
susceptible to oxytetracycline.
    (iii) Limitations. Feed continuously for 7 to 14 days; do not feed 
to chickens producing eggs for human consumption; withdraw 5 days 
before slaughter; do not use in feeds containing bentonite; feed must 
be used within 50 days of manufacture; oxytetracycline as provided by 
No. 000069 of this chapter.

    Dated: September 16, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-25257 Filed 10-2-96; 8:45 am]
BILLING CODE 4160-01-F