[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Rules and Regulations]
[Page 6764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2451]


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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 two supplemental new animal 
drug applications (NADAs) filed by Schering-Plough Animal Health Corp. 
The supplemental NADAs provide for the addition of statements to 
labeling of subcutaneous implants containing zeranol warning against 
the use of these products in calves to be processed for veal.

DATES:  This rule is effective February 9, 2005.

FOR FURTHER INFORMATION CONTACT:  Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed a supplement to NADA 38-233 for 
RALGRO (zeranol) and to NADA 141-192 for RALGRO LA (zeranol), two 
subcutaneous implants/products used in certain classes of cattle or in 
sheep for improved feed efficiency and/or increased rate of weight 
gain. The supplemental NADAs provide for the addition of statements to 
labeling warning against the use of these products in calves to be 
processed for veal. The supplemental applications are approved as of 
January 14, 2005, and the regulations are amended in 21 CFR 522.2680 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications may be seen in the Division of Dockets Management 
(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.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 in 21 CFR Part 522

    Animal drugs.

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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

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. Section 522.2680 is amended by revising paragraphs (d)(1)(iii), 
(d)(2)(iii), (d)(3)(iii), and (d)(4)(iii) to read as follows:


Sec.  522.2680  Zeranol.

* * * * *
    (d) * * *
    (1) * * *
    (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. Safety and effectiveness have not been established in 
veal calves. A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
    (2) * * *
    (iii) Limitations. Implant subcutaneously in ear only. Do not use 
in breeding animals. Do not implant animals within 40 days of 
slaughter. Safety and effectiveness have not been established in veal 
calves. A withdrawal period has not been established for this product 
in preruminating calves. Do not use in calves to be processed for veal.
    (3) * * *
    (iii) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (4) * * *
    (iii) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

    Dated: January 27, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-2451 Filed 2-8-05; 8:45 am]
BILLING CODE 4160-01-S