[Federal Register Volume 64, Number 166 (Friday, August 27, 1999)]
[Rules and Regulations]
[Pages 46839-46840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Zeranol
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 Schering-Plough Animal Health Corp. The
supplemental NADA provides for use of a zeranol implant in steers fed
in confinement for slaughter for improved feed efficiency.
EFFECTIVE DATE: August 27, 1999.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-1600.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095
Morris Ave., P.O. Box 3182, Union, NJ 07083-1982, filed supplemental
NADA 38-233 that provides for use of Ralgro Magnum (zeranol)
implant in steers being fed in confinement for slaughter at a dose of
72 milligrams per steer for improved feed efficiency. The supplemental
NADA is approved as of June 25, 1999, and the regulations are amended
in 21 CFR 522.2680(d)(3)(ii) 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852, 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 (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
for food-producing animals qualifies for 3 years of marketing
exclusivity beginning June 25, 1999, because the supplemental
application 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 and conducted or sponsored by
the applicant. Three years marketing exclusivity is limited to use of
the drug for improved feed efficiency in steers fed in confinement for
slaughter.
FDA has carefully considered the potential environmental impact of
this action and has concluded that the action will not have a
significant impact on the human environment and an environmental impact
statement is not required. FDA'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 rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects 21 CFR Part 522
Animal drugs.
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 522 is
amended as follows:
[[Page 46840]]
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.2680 [Amended]
2. Section 522.2680 Zeranol is amended in paragraph (d)(3)(ii) by
removing ``For increased rate of weight gain'' and adding in its place
``For increased rate of weight gain and improved feed efficiency''.
Dated: August 2, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaulation, Center for Veterinary
Medicine.
[FR Doc. 99-22312 Filed 8-26-99; 8:45 am]
BILLING CODE 4160-01-F
