[Federal Register Volume 63, Number 74 (Friday, April 17, 1998)]
[Rules and Regulations]
[Pages 19184-19185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10251]


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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; Bacitracin Zinc; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulation for use of bacitracin zinc Type A medicated articles to 
make Type C medicated feeds

[[Page 19185]]

in combination with other drugs to include certain other drugs that 
have been approved elsewhere in the animal drug regulations. This 
action is being taken to ensure the accuracy and consistency of the 
regulation because the cross-references were not updated at the time 
the combination drug uses were approved.

EFFECTIVE DATE: April 17, 1998.

FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary 
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1739.

SUPPLEMENTARY INFORMATION: In Sec. 558.78(d)(3) (21 CFR 558.78(d)(3)) 
FDA codified a list of combinations in which bacitracin zinc is 
approved for use with certain drugs that have been approved elsewhere 
in 21 CFR part 558. Several cross-references to approved combination 
drug uses were not included in that list. Section 558.78(d)(3) is 
amended to add those cross-references.

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: 21 U.S.C. 360b, 371.

    2. Section 558.78 is amended by revising paragraph (d)(3) to read 
as follows:


Sec. 558.78  Bacitracin zinc.

* * * * *
     (d)  * * *
    (3) Bacitracin zinc may be used as approved in combination as 
follows:
    (i) Amprolium as in Sec. 558.55.
    (ii) Amprolium and roxarsone as in Sec. 558.55.
    (iii) Amprolium and ethopabate as in Sec. 558.58.
    (iv) Amprolium and ethopabate with roxarsone as in Sec. 558.58.
    (v) Carbarsone as in Sec. 558.120.
    (vi) Clopidol as in Sec. 558.175.
    (vii) Clopidol and roxarsone as in Sec. 558.175.
    (viii) Decoquinate as in Sec. 558.195.
    (ix) Decoquinate and roxarsone as in Sec. 558.195.
    (x) Hygromycin B as in Sec. 558.274.
    (xi) Hygromycin B and penicillin as in Sec. 558.274.
    (xii) Lasalocid sodium and roxarsone as in Sec. 558.311.
    (xiii) Monensin as in Sec. 558.355.
    (xiv) Monensin and roxarsone as in Sec. 558.355.
    (xv) Robenidine as in Sec. 558.515.
    (xvi) Salinomycin as in Sec. 558.550.
    (xvii) Salinomycin and roxarsone as in Sec. 558.550.
    (xviii) Zoalene as in Sec. 558.680.
    (xix) Zoalene and arsanilic acid as in Sec. 558.680.
    (xx) Zoalene and roxarsone as in Sec. 558.680.

    Dated: March 31, 1998.
Andrew J. Beaulieu,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-10251 Filed 4-16-98; 8:45 am]
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