[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
