[Federal Register Volume 64, Number 54 (Monday, March 22, 1999)]
[Rules and Regulations]
[Page 13679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6669]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs for Use in Animal Feeds; Tilmicosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 for veterinary prescription use of 
tilmicosin Type C medicated swine feeds under a veterinary feed 
directive (VFD) provides a revised limitation to prevent accidental 
access by horses. Also, FDA amends the regulation to provide a swine 
muscle tolerance and an acceptable daily intake (ADI).

EFFECTIVE DATE: March 22, 1999.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7570.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, is sponsor 
of NADA 141-064 that provides for the use of Pulmotil 
(tilmicosin) Type A medicated article to make Type B and Type C 
medicated swine feeds for control of swine respiratory disease. The 
drug is limited to use by or on the order of a licensed veterinarian 
under an approved VFD. The firm filed a supplemental NADA that provided 
for a revised limitation to prevent accidental access by horses. Also, 
FDA reviewed the information in the application and revised the 
regulation to provide an ADI and a swine muscle tolerance. The 
supplemental NADA is approved as of February 2, 1999, and the 
regulations in 21 CFR 556.735 and 558.618 are amended 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 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 supplemental 
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(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.

List of Subjects

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.
    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 556 and 
558 are amended as follows:

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

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

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

    2. Section 556.735 is revised to read as follows:


Sec. 556.735  Tilmicosin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
tilmicosin is 25 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. A tolerance is established for residues 
of parent tilmicosin (marker residue) in liver (target tissue) at 1.2 
parts per million (ppm).
    (2) Swine. A tolerance is established for residues of parent 
tilmicosin (marker residue) in liver (target tissue) at 7.5 ppm and in 
muscle at 0.1 ppm.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
    4. Section 558.618 is amended in paragraph (d)(3) by adding a new 
sentence after the second sentence to read as follows:


Sec. 558.618   Tilmicosin

* * * * *
    (d) * * *
    (3) * * * Do not allow horses or other equine access to feeds 
containing tilmicosin. * * *
* * * * *

    Dated: February 26, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-6669 Filed 3-19-99; 8:45 am]
BILLING CODE 4160-01-F