[Federal Register: May 2, 2002 (Volume 67, Number 85)]
[Rules and Regulations]               
[Page 21996-21997]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 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. The supplemental NADA 
provides for additions to labeling of tilmicosin for use in swine feed.

DATES: This rule is effective May 2, 2002.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 141-064 that provides for the use of PULMOTIL 
(tilmicosin phosphate) Type A medicated article in swine feed for the 
control of swine respiratory disease associated with certain bacterial 
organisms. The supplemental NADA provides for additional use 
information in labeling. The supplemental NADA is approved as of 
November 15, 2001, and the regulations are amended in 21 CFR 558.618 to 
reflect the approval.
    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.
    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 
    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 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 part 558 is 
amended as follows:

[[Page 21997]]


    1. The authority citation for 21 CFR part 558 continues to read as 

    Authority: 21 U.S.C. 360b, 371.
    2. Section 558.618 is amended by redesignating paragraphs (a) 
through (d) as paragraphs (b) through (e), respectively; by adding new 
paragraph (a); and by revising newly redesignated paragraphs (b), (c), 
and (e)(3) to read as follows:

Sec.  558.618  Tilmicosin.

    (a) Specifications. Type A medicated article containing 20 percent 
tilmicosin as tilmicosin phosphate (90.7 grams per pound).
    (b) Approvals. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. (1) Federal law limits this drug to use 
under the professional supervision of a licensed veterinarian. See 
Sec. 558.6 of this chapter for additional requirements for the use of 
products regulated as veterinary feed directives (VFDs).
    (2) The expiration date of VFDs for tilmicosin must not exceed 90 
days from the time of issuance. VFDs for tilmicosin shall not be 
    (3) Do not use in Type B or Type C medicated feeds containing 
* * * * *
    (e) * * * 
    (3) Limitations. Feed continuously as the sole ration for 21-day 
period, beginning approximately 7 days before an expected disease 
outbreak. Feed containing tilmicosin shall not be fed to pigs for more 
than 21 days during each phase of production without ceasing 
administration for reevaluation of antimicrobial use by a licensed 
veterinarian before reinitiating a further course of therapy with an 
appropriate antimicrobial. The safety of tilmicosin has not been 
established in pregnant swine or swine intended for breeding purposes. 
Do not allow horses or other equines access to feeds containing 
tilmicosin. Withdraw 7 days before slaughter.

    Dated: April 9, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-10792 Filed 5-1-02; 8:45 am]