[Federal Register Volume 61, Number 165 (Friday, August 23, 1996)]
[Rules and Regulations]
[Pages 43450-43451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21483]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Semduramicin with 
Bacitracin Methylene Disalicylate and Roxarsone; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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[[Page 43451]]

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of June 11, 1996 (61 FR 
29481). That document amended the animal drug regulations to reflect 
approval for use of single ingredient Type A medicated articles to make 
combination drug Type C medicated broiler chicken feeds containing 
semduramicin with bacitracin methylene disalicylate and roxarsone. That 
document failed to designate the approved sources for the drugs. This 
document amends the regulation to provide that information. In 
addition, certain cross-references are added in the animal feed 
regulations.

EFFECTIVE DATE: August 23, 1996.

FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1607.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 11, 1996 (61 
FR 29481), FDA announced the approval of Pfizer, Inc.'s new animal drug 
application (NADA) 141-058, which provides for use of approved single 
ingredient Type A medicated articles containing AviaxTM 
(semduramicin sodium), BMD (bacitracin methylene 
disalicylate), and 3-Nitro (roxarsone), to make combination 
drug Type C medicated broiler chicken feeds used for the prevention of 
coccidiosis and improved feed efficiency. That document failed to state 
the source of the approved Type A medicated articles. It also failed to 
amend related regulations to provide for cross-references to these 
uses. This document amends the regulations in 21 CFR 558.76(d)(3)(xiv), 
558.530(d)(5)(xxiv), and 558.555(b)(2)(ii) to provide for the cross-
references and sources.

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).

    -2. Section 558.76 is amended by adding new paragraph (d)(3)(xiv) 
to read as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (xiv) Semduramicin with roxarsone as in Sec. 558.555.
    3. Section 558.530 is amended by adding new paragraph (d)(5)(xxiv) 
to read as follows:


Sec. 558.530  Roxarsone.

* * * * *
    (d) * * *
    (5) * * *
    (xxiv) Semduramicin with bacitracin methylene disalicylate as in 
Sec. 558.555.
* * * * *
    4. Section 558.555 is amended by adding a sentence at the end of 
paragraph (b)(2)(ii) to read as follows:


Sec. 558.555  Semduramicin.

* * * * *
    (b) * * *
    (2) * * *
    (ii) * * * Semduramicin as provided by 000069 in Sec. 510.600(c) of 
this chapter, bacitracin methylene disalicylate and roxarsone as 
provided by 046573.

    Dated: August 14, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-21483 Filed 8-22-96; 8:45 am]
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