[Federal Register Volume 60, Number 95 (Wednesday, May 17, 1995)]
[Rules and Regulations]
[Pages 26359-26360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12094]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation and 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 Mallinckrodt Veterinary, Inc. The 
supplemental NADA provides for use of a 72-milligram (mg) zeranol 
implant in steers being fed in confinement for slaughter for increased 
rate of weight gain.

EFFECTIVE DATE: May 17, 1995.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0217.

SUPPLEMENTARY INFORMATION: Mallinckrodt Veterinary, Inc., 421 East 
Hawley St., Mundelein, IL 60060, filed supplemental NADA 38-233 to 
provide for the use of Ralgro Magnum (a 72-mg zeranol implant) in 
steers being fed in confinement for slaughter for increased rate of 
weight gain (i.e., use of six 12-mg zeranol pellets). The supplemental 
NADA is approved as of April 6, 1995, and the regulations are amended 
in 21 CFR 522.2680(d) 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 [[Page 26360]] (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., 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 (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning April 6, 1995, because the supplemental NADA contains reports 
of new clinical investigations (other than bioequivalence or residue 
studies) essential to the approval and conducted or sponsored by the 
applicant. Three years of marketing exclusivity applies only to the use 
for which the supplemental NADA is approved.
    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.

List of Subjects in 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:

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

     2. Section 522.2680 is amended by adding new paragraph (d)(3) to 
read as follows:


Sec. 522.2680  Zeranol.

 * * * * *
     (d) *  *   *
     (3) Steers--(i)  Amount. 72 milligrams (six 12-milligram pellets) 
per animal.
     (ii) Indications for use. For increased rate of weight gain in 
steers fed in confinement for slaughter.
     (iii) Limitations. Implant subcutaneously in ear only.

    Dated: May 5, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-12094 Filed 5-16-95; 8:45 am]
BILLING CODE 4160-01-F