[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
