[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Pages 66583-66584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32035]


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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

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 new animal drug application 
(NADA) filed by Pfizer, Inc. The NADA provides for using approved 
single ingredient Type A medicated articles to make combination drug 
Type C medicated broiler chicken feeds containing semduramicin with 
bacitracin methylene disalicylate. The Type C medicated feed is used 
for prevention of coccidiosis and for improved feed efficiency.

EFFECTIVE DATE:  December 18, 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: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-065, which provides for combining approved Type A 
medicated articles containing AviaxTM (semduramicin sodium) with 
BMD (bacitracin methylene disalicylate) to make combination 
drug Type C medicated broiler chicken feed containing 22.7 grams (g) of 
semduramicin and 10 to 50 g of bacitracin methylene disalicylate. The 
Type C medicated feed is used for the prevention of coccidiosis caused 
by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. 
necatrix, and E. tenella, and for improved feed efficiency in broiler 
chickens. The NADA is approved as of October 18, 1996, and the 
regulations are amended by revising 21 CFR 558.76(d)(3)(xiv) and by 
adding 21 CFR 558.555(b)(3) 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 66584]]

    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years marketing exclusivity beginning October 18, 1996, because the 
application contains reports of new clinical or field investigations 
(other than bioequivalence or residue studies) essential to the 
approval of the application and conducted or sponsored by the 
applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(ii) 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 
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 revising paragraph (d)(3)(xiv) to 
read as follows:


Sec. 558.76  Bacitracin methylene disalicylate

* * * * *
    (d) * * *
    (3) * * *
    (xiv) Semduramicin alone or in combination with roxarsone as in 
Sec. 558.555.

    3. Section 558.555 is amended by adding new paragraph (b)(3) to 
read as follows:


Sec. 558.555  Semduramicin.

* * * * *
    (b) * * *
    (3) Amount. Semduramicin 22.7 grams with bacitracin methylene 
disalicylate 10 to 50 grams per ton.
    (i) Indications for use. For the prevention of coccidiosis caused 
by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. 
necatrix, and E. tenella, and for improved feed efficiency in broiler 
chickens.
    (ii) Limitations. Feed continuously as sole ration. Use feed within 
2 weeks of production. Do not feed to laying hens. Semduramicin as 
provided by 000069, bacitracin methylene disalicylate as provided by 
046573 in Sec. 510.600(c) of this chapter.

    Dated: December 6, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32035 Filed 12-17-96; 8:45 am]
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