[Federal Register Volume 60, Number 25 (Tuesday, February 7, 1995)]
[Rules and Regulations]
[Page 7121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2990]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; 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 Premiere Agri Technologies, Inc., providing
for making a 20-gram-per-pound (g/lb) tylosin Type A medicated article
in addition to existing approvals for 40- and 100-g/lb Type A medicated
articles.
EFFECTIVE DATE: February 7, 1995
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1700.
SUPPLEMENTARY INFORMATION: Premiere Agri Technologies, Inc. (Premiere),
P.O. Box 2508, Fort Wayne, IN 46801-2508, filed a supplement to NADA
91-582 (formerly sponsored by Central Soya Co., Inc.) that provides for
making a new 20-g/lb tylosin Type A medicated article used to make Type
C medicated feeds for cattle, chickens, and swine for use as in
Sec. 558.625(f)(1)(i) through (f)(1)(vi) (21 CFR 558.625(f)(1)(i)
through (f)(1)(vi)). Premiere currently has approval for 40- and 100-g/
lb Type A medicated articles. The supplemental NADA is approved and the
regulations are amended in Sec. 558.625(b)(10) to reflect the approval.
Approval of this supplemental NADA is an administrative action that
did not require the generation of new safety or effectiveness data.
Therefore, a freedom of information summary is not required for this
action.
The agency has determined under 21 CFR 25.24(d)(1)(iii) 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 558
Animal drugs, Animal feeds.
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 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).
2. Section 558.625 is amended by revising paragraph (b)(10) to read
as follows:
Sec. 558.625 Tylosin.
* * * * *
(b) * * *
(10) To 012286: 0.4, 0.8, and 1.6 grams per pound, paragraph
(f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound,
paragraphs (f)(1)(i) through (f)(1)(vi) of this section.
* * * * *
Dated: January 11, 1995.
Andrew J. Beaulieau,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 95-2990 Filed 2-6-95; 8:45 am]
BILLING CODE 4160-01-F
