[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Rules and Regulations]
[Page 8547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Tylosin and
Virginiamycin
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 remove those portions reflecting approval of four
new animal drug applications (NADA's) held by Premiere Agri
Technologies, Inc. The NADA's provide for use of Type A medicated
articles and Type B medicated feeds containing tylosin and Type B
medicated feeds containing virginiamycin. In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of the NADA's.
EFFECTIVE DATE: February 27, 1995.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this
issue of the Federal Register, FDA is withdrawing approval of the
following NADA's:
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Sponsor name and
NADA No. Drug name address
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45-690................. Tylosin Type B Premiere Agri
medicated feeds and Technologies, Inc.,
Type A medicated P.O. Box 2508, Fort
article. Wayne, IN 46801-2508
(former sponsor
Henwood Feed
Additives)
97-289................. Tylosin Type B Do. (Former sponsor
medicated feeds and Feed Specialties Co.,
Type A medicated Inc.)
article.
133-361................ Virginiamycin Type B Do. (Former sponsor
medicated feed. Feed Specialties Co.,
Inc.)
133-839................ Virginiamycin Type B Do. (Former sponsor
medicated feed. Mac-Page, Inc.)
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The sponsor requested withdrawal of approval of the NADA's. This
final rule removes 21 CFR 558.625(b)(11) and (b)(15) and amends 21 CFR
558.635(b)(2) to reflect the withdrawal of approval of these NADA's.
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. 558.625 [Amended]
2. Section 558.625 Tylosin is amended by removing and reserving
paragraphs (b)(11) and (b)(15).
3. Section 558.635 Virginiamycin is amended by revising paragraph
(b)(2) to read as follows:
Sec. 558.635 Virginiamycin
* * * * *
(b) * * *
(2) 2.2 percent activity (10 grams per pound) to 011490, 016968,
and 017790 in Sec. 510.600(c) of this chapter for use as in paragraphs
(f)(1)(iv) and (f)(1)(v) of this section.
* * * * *
Dated: January 6, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-3802 Filed 2-14-95; 8:45 am]
BILLING CODE 4160-01-F
