[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Rules and Regulations]
[Page 67713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32549]


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


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Tylosin

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, Division of Eli Lilly 
and Co. The supplemental NADA provides for use of tylosin Type A 
medicated articles to make Type C medicated swine feeds for prevention 
and/or control of porcine proliferative enteropathies (ileitis) 
associated with Lawsonia intracellularis.

EFFECTIVE DATE: December 24, 1996.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, Division of Eli Lilly 
and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
supplemental NADA 12-491, which provides for use of 40 and 100 grams 
per pound (g/lb) tylosin Type A medicated articles to make 100 g/ton 
tylosin Type C medicated feeds to be fed for 21 days for the prevention 
and/or control of porcine proliferative enteropathies (ileitis) 
associated with Lawsonia intracellularis. The supplemental NADA is 
approved as of November 8, 1996, and the regulations are amended by 
adding new 21 CFR 558.625(f)(1)(vi)(e) to reflect the approval.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning November 8, 1996, because the supplement contains substantial 
evidence of the effectiveness of the drug involved, studies of animal 
safety, or in the case of food-producing animals, human food safety 
studies (other than bioequivalence or residue studies) required for 
approval of the supplement and conducted or sponsored by the applicant.
    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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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 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 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    2. Section 558.625 is amended by adding new paragraph (f)(1)(vi)(e) 
to read as follows:

Sec. 558.625  Tylosin.

* * * * *
    (f) * * *
    (1) * * *
    (vi) * * *
    (e) (1) Indications for use. Prevention and/or control of porcine 
proliferative enteropathies (ileitis) associated with Lawsonia 
intracellularis.
    (2) Limitations. As tylosin phosphate, administer for 21 days.

    Dated: December 5, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-32549 Filed 12-23-96; 8:45 am]
BILLING CODE 4160-01-F