[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Rules and Regulations]
[Page 17329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9428]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Neomycin Sulfate Soluble
Powder
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 an abbreviated new animal drug
application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for
use of neomycin sulfate soluble powder in water or milk as a drench or
in drinking water for the treatment and control of colibacillosis in
cattle (excluding veal calves), swine, sheep, and goats.
EFFECTIVE DATE: April 9, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767-1861, filed ANADA 200-235 that provides for use of
neomycin sulfate soluble powder in water or milk as a drench or in
drinking water for the treatment and control of colibacillosis
(bacterial enteritis) caused by Escherichia coli susceptible to
neomycin sulfate in cattle (excluding veal calves), swine, sheep, and
goats.
Med-Pharmex, Inc.'s ANADA 200-235 is approved as a copy of Upjohn's
NADA 11-315. The ANADA is approved as of March 9, 1998, and the
regulations are amended in Sec. 520.1484 (21 CFR 520.1484) to reflect
the approval. The basis for approval is discussed in the freedom of
information summary.
Also, the regulation incorrectly indicates that Phoenix Scientific,
Inc., has an approved neomycin sulfate soluble powder product. At this
time, the regulation is amended by removing the sponsor for Phoenix
Scientific, Inc., in Sec. 520.1484(b) and by revising paragraph (c)(3).
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this application
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) 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
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: 21 U.S.C. 360b.
2. Section 520.1484 is amended by revising paragraph (b) and the
last sentence of paragraph (c)(3) to read as follows:
Sec. 520.1484 Neomycin sulfate soluble powder.
* * * * *
(b) Sponsors. See Nos. 000009, 000069, 046573, 050604, and 051259
in Sec. 510.600(c) of this chapter.
(c) * * *
(3) * * * Discontinue treatment prior to slaughter as follows:
Cattle (not for use in veal calves), 1 day; sheep, 2 days; swine and
goats, 3 days.
Dated: March 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-9428 Filed 4-8-98; 8:45 am]
BILLING CODE 4160-01-F
