[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36179-36180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Penicillin

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 two supplemental new animal 
drug applications (NADA's), one filed by Alpharma Inc., the other by 
Pfizer, Inc. The supplemental NADA's provide for using approved 
penicillin G procaine Type A medicated articles to make Type C 
medicated chicken, turkey, pheasant, quail, and swine feeds used for 
increased rate of weight gain and improved feed efficiency.

EFFECTIVE DATE: July 2, 1998.

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: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of NADA 46-666. Pfizer, Inc., 235 
East 42d St., New York, NY 10017, is sponsor of NADA 46-668. The 
sponsors filed supplemental NADA's that provide for amending the 
regulations concerning use of penicillin Type A medicated articles to 
make Type B and C medicated feeds for chickens, turkeys, pheasants, 
quail, and swine for increased rate of weight gain and improved feed 
efficiency. The supplemental NADA's reflect the results of the National 
Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy 
Study Implementation (DESI) review of the products' effectiveness and 
FDA's conclusions based on that review (35 FR 11533, July 17, 1970).
    NAS/NRC evaluated these products as probably effective for faster 
gain and/or feed efficiency. FDA concurred with these findings and 
concluded that the appropriate claim should be ``for increased rate of 
weight gain and improved feed efficiency for (under appropriate 
conditions of use).'' The evaluation concerned only the drug's 
effectiveness and safety to the animal to which administered, and it 
did 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 as residues in food products derived from treated animals.
    In the Federal Register of August 30, 1977 (42 FR 43772), the then 
Bureau of Veterinary Medicine issued a notice of opportunity for 
hearing (NOOH) on a proposal to withdraw approval of NADA's for all 
penicillin-containing premixes (Type A medicated articles) intended for 
subtherapeutic use in animal feeds. 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 penicillin-containing Type A 
medicated articles does not constitute a bar to subsequent action to 
withdraw approval on the grounds cited in the outstanding NOOH.
    The supplemental NADA's are approved as of April 10, 1998. The 
regulations are amended in 21 CFR 558.460 by redesignating paragraphs 
(b) and (c) as paragraphs (c) and (d), by adding new paragraph (b), and 
by revising the table in paragraph (d) to reflect the approval. The 
basis for approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(3) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the 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: 21 U.S.C. 360b, 371.

    2. Section 558.460 is amended by redesignating paragraphs (b) and 
(c) as paragraphs (c) and (d), by adding paragraph (b), and by revising 
the table in paragraph (d)(1) to read as follows:


 Sec. 558.460  Penicillin.

* * * * *
    (b) Sponsors. Type A medicated articles: To 000069, 100 grams per 
pound. To 046573, 100 and 227 grams per pound.
* * * * *
    (d) * * *
    (1) * * *

                                                                        
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                     Combination                                        
   Penicillin in     in grams per   Indications    Limitations   Sponsor
   grams per ton         ton          for use                           
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(i) 2.4 to 50                      Chickens,      Do not feed   000069, 
                                    turkeys, and   to poultry    046573.
                                    pheasants;     producing            
                                    for            eggs for             
                                    increased      human                
                                    rate of        consumption          
                                    weight gain    .                    
                                    and improved                        
                                    feed                                
                                    efficiency.                         
(ii) 5 to 20                       Quail; for     Quail; not    Do.     
                                    increased      over 5               
                                    rate of        weeks of             
                                    weight gain    age.                 
                                    and improved                        
                                    feed                                
                                    efficiency.                         

[[Page 36180]]

                                                                        
(iii) 10 to 50                     Swine; for     ............  Do.     
                                    increased                           
                                    rate of                             
                                    weight gain                         
                                    and improved                        
                                    feed                                
                                    efficiency.                         
------------------------------------------------------------------------

* * * * *

    Dated: June 22, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-17546 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F