[Federal Register: May 2, 2002 (Volume 67, Number 85)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
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
[FR Doc. 02-10792 Filed 5-1-02; 8:45 am]
BILLING CODE 4160-01-S