[Federal Register Volume 62, Number 141 (Wednesday, July 23, 1997)]
[Rules and Regulations]
[Page 39443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Tylosin

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, Division of Eli Lilly 
and Co. The supplemental NADA provides for use of tylosin to make a 
medicated drinking water for chickens, turkeys, and swine for control 
and/or treatment of infections sensitive to tylosin.

EFFECTIVE DATE: July 23, 1997.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, Division of Eli Lilly 
and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
supplemental NADA 13-076 that provides for use of packages containing 
the equivalent of 100 grams (g) of tylosin to make 50 gallons of 
chicken and turkey drinking water, and one-half package or 50 g of 
tylosin to make 200 gallons of swine drinking water, to treat tylosin 
sensitive infections. The tylosin base soluble powder approved under 
NADA 13-029 for swine and the tylosin tartrate soluble powder approved 
under NADA 13-076 for chickens and turkeys are considered to be DESI-
equivalent based on the findings of the National Academy of Sciences/
National Research Council (NAS/NRC) review of the products and FDA's 
conclusions based on that review, and should have been DESI-finalized 
as one application. The supplement provides for incorporating NADA 13-
029 into NADA 13-076 and in a separate action, withdrawing approval of 
NADA 13-029. The supplemental NADA is approved as of May 27, 1997, and 
the regulations are amended in 21 CFR 520.2640 to reflect the approval.
    Approval of this supplement is an administrative action that did 
not require submission of added safety or efficacy data. Accordingly, a 
freedom of information summary is not required.
    FDA 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 520

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. 520.2640  [Amended]

    2. Section 520.2640 Tylosin is amended in paragraphs (e)(1)(iii) 
and (e)(2)(iii) by removing the phrase ``as tylosin tartrate'', and in 
paragraph (e)(3)(iii) by removing the phrase ``present as tylosin 
base''.

    Dated: July 7, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-19245 Filed 7-22-97; 8:45 am]
BILLING CODE 4160-01-F