[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
