[Federal Register Volume 67, Number 234 (Thursday, December 5, 2002)]
[Rules and Regulations]
[Pages 72367-72368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


New Animal Drugs; Tilmicosin

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 Elanco Animal Health, A Division of Eli 
Lilly & Co. The supplemental NADA provides for subcutaneous injection 
of tilmicosin phosphate solution for the treatment of ovine respiratory 
disease (ORD). FDA is also amending the regulations to add tolerances 
for residues of tilmicosin in sheep muscle and liver and in cattle 
muscle.

DATES: This rule is effective December 5, 2002.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7569, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplemental application to NADA 140-929 that provides for the use of 
MICOTIL 300 (tilmicosin phosphate) Injection by subcutaneous injection 
for the treatment of ORD associated with Mannheimia (Pasteurella) 
haemolytica. The supplemental NADA is approved as of September 4, 2002, 
and the regulations are amended in 21 CFR 522.2471 and Sec.  556.735 
(21 CFR 556.735) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, Sec.  556.735 is amended by adding a tolerance for 
residues of tilmicosin in sheep muscle and liver and in cattle muscle, 
and editorially, to reflect a current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, 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(d)(4) 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

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 522.2471 is revised to read as follows:

[[Page 72368]]

Sec.  522.2471  Tilmicosin.

    (a) Specifications. Each milliliter of solution contains 300 
milligrams (mg) tilmicosin base as tilmicosin phosphate.
    (b) Sponsor. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.735 of this chapter.
    (d) Special considerations. (1) Not for human use. Use of this 
antibiotic in humans may prove fatal. Do not use in automatically 
powered syringes.
    (2) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) Conditions of use--(1) Cattle--(i) Amount. 10 mg per kilogram 
(kg) body weight as a single subcutaneous injection.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia (Pasteurella) haemolytica. For 
the control of respiratory disease in cattle at high risk of developing 
BRD associated with Mannheimia (P.) haemolytica.
    (iii) Limitations. Do not use in female dairy cattle 20 months of 
age or older. Use of this antibiotic in this class of cattle may cause 
milk residues. Do not slaughter within 28 days of last treatment.
    (2) Sheep--(i) Amount. 10 mg/kg body weight as a single 
subcutaneous injection.
    (ii) Indications for use. For the treatment of ovine respiratory 
disease (ORD) associated with Mannheimia (P.) haemolytica.
    (iii) Limitations. Do not slaughter within 28 days of last 
treatment.

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 556.735 is amended by revising paragraph (b) to read as 
follows:


Sec.  556.735  Tilmicosin.

* * * * *
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent tilmicosin (the marker residue) is 1.2 parts per 
million (ppm).
    (ii) Muscle. The tolerance for parent tilmicosin (the marker 
residue) is 0.1 ppm.
    (2) Swine--(i) Liver (the target tissue). The tolerance for parent 
tilmicosin (the marker residue) is 7.5 ppm.
    (ii) Muscle. The tolerance for parent tilmicosin (the marker 
residue) is 0.1 ppm.
    (3) Sheep--(i) Liver (the target tissue). The tolerance for parent 
tilmicosin (the marker residue) is 1.2 ppm.
    (ii) Muscle. The tolerance for parent tilmicosin (the marker 
residue) is 0.1 ppm.

    Dated: November 21, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-30864 Filed 12-4-02; 8:45 am]
BILLING CODE 4160-01-S