[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Page 14305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Salinomycin

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 Hoffmann-LaRoche, Inc. The supplement 
provides for use of an approved salinomycin Type A medicated article to 
make Type C roaster and replacement chicken feeds used for prevention 
of certain forms of coccidiosis.

EFFECTIVE DATE: May 27, 1997.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Hoffmann-LaRoche, Inc., 340 Kingsland St., 
Nutley, NJ 07110-1199, filed supplemental NADA 128-686 that provides 
for use of a 30-gram-per-pound salinomycin Type A article (as 
salinomycin sodium) to make Type C roaster and replacement (breeder and 
layer) chicken feeds containing 40 to 60 grams per ton salinomycin 
sodium activity for prevention of coccidiosis caused by Eimeria 
tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. 
mivati. This supplement is approved as of February 3, 1997, and the 
regulations are amended in 21 CFR 558.550 to reflect the approval. The 
basis of 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.
     Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval 
for food-producing animals qualifies for 3 years of marketing 
exclusivity beginning February 3, 1997, because the supplement contains 
substantial evidence of the effectiveness of the drug involved, any 
studies of animal safety or, in the case of food producing animals, 
human food safety studies (other than bioequivalence or residue 
studies) required for approval of the supplement and conducted or 
sponsored by the applicant.
    The agency has carefully considered the potential environmental 
effects of this action. 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.
    This approval is for use of salinomycin Type A medicated articles 
to make Type C medicated feeds. Salinomycin is a category I drug as 
defined in 21 CFR 558.3(b)(1)(i). As provided in 21 CFR 558.4(b), an 
approved Form FDA 1900 is not required for making a Type C medicated 
feed as provided in the NADA. Under section 512(m) of the act, as 
amended by the Animal Drug Availability Act of 1996 (Pub. L. 104-250), 
medicated feed applications have been replaced by feed mill licensing.

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

     2. Section 558.550 is amended by redesignating paragraph (b)(3) as 
paragraph (b)(4) and by adding new paragraph (b) (3) to read as follows

Sec. 558.550  Salinomycin.

 *   *   *   *   *
     (b) *   *   *
    (3) Roaster and replacement (breeder and layer) chickens: It is 
used as follows:
    (i) Amount per ton. Salinomycin 40 to 60 grams.
    (ii) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati.
    (iii) Limitations. Feed continuously as sole ration. Do not feed to 
laying hens producing eggs for human consumption. Not approved for use 
with pellet binders. May be fatal if accidentally fed to horses or 
adult turkeys.

    Dated: March 17, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-7543 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F