[Federal Register Volume 67, Number 31 (Thursday, February 14, 2002)]
[Rules and Regulations]
[Pages 6866-6867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


Implantation or Injectable Dosage Form New Animal Drugs; Zeranol

AGENCY: Food and Drug Administration, HHS.

[[Page 6867]]


ACTION: Final rule, technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides 
for use of a subcutaneous ear implant containing zeranol in pasture 
cattle for increased rate of weight gain. FDA is also amending the 
regulations to add the acceptable daily intake (ADI) for total residues 
of zeranol.

DATES: This rule is effective February 14, 2002.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 3182, Union, NJ 07083, filed NADA 141-192 for 
RALGRO LA (zeranol), a subcutaneous ear implant containing 138 
milligrams (mg) zeranol. The implants are used for increased rate of 
weight gain for up to 210 days in pasture cattle (slaughter, stocker, 
and feeder steers, and heifers). The application is approved as of 
November 1, 2001, and the regulations are amended in Sec. 522.2680 (21 
CFR 522.2680) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    Section 522.2680 is also being amended to reflect a current format 
for regulations pertaining to cattle ear implants. This action is being 
taken to improve the clarity and readability of the regulations. In 
addition, the regulations are amended in 21 CFR 556.760 by adding the 
previously established ADI for total residues of zeranol, and 
editorially, to reflect current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning November 1, 2001, because the 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 the approval and conducted or sponsored by the 
applicant.
    The agency 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 that 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.

21 CFR Part 556

    Animal drugs, Foods.

    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 parts 522 and 
556 are 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: 21 U.S.C. 360b.

    2. Section 522.2680 is amended by revising paragraphs (a), 
(d)(1)(i), (d)(2)(i), (d)(3)(i), and (d)(3)(ii), and by adding 
paragraph (d)(4) to read as follows:


Sec. 522.2680  Zeranol.

    (a) Specifications. Each pellet contains 12, 18, or 20 milligrams 
(mg) zeranol.
* * * * *
    (d) Conditions of use--(1) Beef cattle--(i) Amount. 36 mg zeranol 
(one implant consisting of 3 pellets, each pellet containing 12 mg 
zeranol) per implant dose.
* * * * *
    (2) Feedlot lambs--(i) Amount. 12 mg zeranol (one implant 
consisting of 1 pellet containing 12 mg zeranol) per implant dose.
* * * * *
    (3) Steers fed in confinement for slaughter--(i) Amount. 72 mg 
zeranol (one implant consisting of 6 pellets, each pellet containing 12 
mg zeranol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
* * * * *
    (4) Pasture cattle (slaughter, stocker, feeder steers, and 
heifers)--(i) Amount. 138 mg zeranol (one implant consisting of 7 
pellets, each of 6 pellets containing 20 mg zeranol and a seventh 
pellet containing 18 mg zeranol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. Implant subcutaneously in ear only.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

    4. Section 556.760 is amended by redesignating paragraphs (a) and 
(b) as paragraphs (b)(1), and (b)(2), respectively, by revising newly 
redesignated paragraph (b)(1), and by adding paragraph (a) to read as 
follows:


Sec. 556.760  Zeranol.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
zeranol is 0.00125 milligrams per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. Tolerances for residues of zeranol in 
edible tissues are not needed.
* * * * *

    Dated: February 1, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-3681 Filed 2-13-02; 8:45 am]
BILLING CODE 4160-01-S