[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
