[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Page 14306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Change of Scientific 
Nomenclature

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 a change of scientific nomenclature from 
Corynebacterium to Actinomyces (Corynebacterium). This change of 
nomenclature is necessary due to the scientific reclassification of the 
organism.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1659.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., 2001 West Main St., P.O. Box 708, Greenfield, IN 46140, 
has informed FDA that the scientific nomenclature for the bacterial 
organism Corynebacterium pyogenes has been changed to Actinomyces 
(Corynebacterium) pyogenes. This change of nomenclature is necessary 
due to scientific reclassification of the organism. The organism causes 
liver abscesses in cattle. Accordingly, the agency is amending the 
regulations in 21 CFR 558.355(f)(3)(ii)(a) and (f)(3)(ix)(a) and 
558.625(f)(1)(i)(b) to reflect this change.

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).

Sec. 558.355  [Amended]

    2. Section 558.355 Monensin is amended in paragraphs (f)(3)(ii)(a) 
and (f)(3)(ix)(a) by removing the word ``Corynebacterium'' and adding 
in its place the words ``Actinomyces (Corynebacterium)''.


Sec. 558.625  [Amended]

    3. Section 558.625 Tylosin is amended in paragraph (f)(1)(i)(b) by 
removing the word ``Corynebacterius'' and adding in its place the words 
``Actinomyces (Corynebacterium)''.

    Dated: March 13, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-7603 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F