[Federal Register Volume 59, Number 79 (Monday, April 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9833]


[[Page Unknown]]

[Federal Register: April 25, 1994]


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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 Pitman-Moore, Inc. The supplemental NADA 
provides for deletion of the caution statement in the labeling against 
the use of a zeranol implant in heifer (suckling beef) calves intended 
for reproduction.

EFFECTIVE DATE: April 25, 1994.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center For Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: Pitman-Moore, Inc., 421 East Hawley St., 
Mundelein, IL 60060, filed a supplemental NADA 038-233 which provides 
for deletion of the caution statement in the labeling against the use 
of a zeranol implant in heifer (suckling beef) calves intended for 
reproduction, and to approve its use with stated limitations. The 
supplemental NADA is approved as of March 30, 1994, and the regulations 
are amended by revising Sec. 522.2680 (21 CFR 522.2680) 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 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, 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 use in 
food-producing animals qualifies for 3 years of marketing exclusivity 
beginning March 30, 1994, because the supplemental NADA contains a 
report of a new clinical investigation (other than a bioequivalence or 
residue study) essential to the approval and conducted or sponsored by 
the applicant. The 3 years of marketing exclusivity applies only to the 
change in the labeling for which the supplemental NADA was approved 
(deletion of the caution statement in the labeling against the use of 
zeranol in heifer (suckling beef) calves intended for reproduction).
    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 revised to read as follows:


Sec. 522.2680  Zeranol.

    (a) Specifications. Each pellet contains 12 milligrams of zeranol.
    (b) Sponsor. See 011716 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.760 of this chapter.
    (d) Conditions of use. For use as a subcutaneous ear implant as 
follows:
    (1) Beef cattle--(i) Amount. 36 milligrams (three 12-milligram 
pellets) per animal.
    (ii) Indications for use--(A) For increased rate of weight gain and 
improved feed conversion in weaned beef calves, growing beef cattle, 
feedlot steers, and feedlot heifers.
    (B) For increased rate of weight gain in suckling calves.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use 
in bulls intended for reproduction or in dairy animals. Do not use 
before 1 month of age or after weaning in heifers intended for 
reproduction.
    (2) Feedlot lambs--(i) Amount. 12 milligrams (1 pellet) per animal.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed conversion.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use 
in breeding animals. Do not implant animals within 40 days of 
slaughter.

    Dated: April 18, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-9833 Filed 4-22-94; 8:45 am]
BILLING CODE 4160-01-F