[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Rules and Regulations]
[Page 31027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15466]
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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 Wade Jones Co., Inc. The ANADA provides
for the use of a generic neomycin sulfate soluble powder in drinking
water and milk for cattle (excluding veal calves), swine, sheep, and
goats for the treatment and control of colibacillosis.
EFFECTIVE DATE: June 19, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Wade Jones Co., Inc., Hwy. 71 North, Lowell,
AK 72745, filed ANADA 200-130, which provides for the use of neomycin
sulfate soluble powder in drinking water and milk for cattle (excluding
veal calves), swine, sheep, and goats for the treatment and control of
colibacillosis (bacterial enteritis) caused by Escherichia coli
susceptible to neomycin sulfate. ANADA 200-130 is approved as a generic
copy of the Upjohn Co.'s NADA 11-315. The ANADA is approved as of May
8, 1996, and the regulations are amended in 21 CFR 520.1484(b) and
(c)(3) to reflect the approval. The basis for approval is discussed in
the freedom of information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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 25.24(d)(1)(i) 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(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, 047864, 050604, and 059130
in Sec. 510.600(c) of this chapter.
(c) * * *
(3) * * * Discontinue treatment prior to slaughter as follows: For
sponsors 000009, 000069, 047864, and 050604--cattle (not for use in
veal calves), 1 day; sheep, 2 days; swine and goats, 3 days.
Dated: June 10, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-15466 Filed 6-18-96; 8:45 am]
BILLING CODE 4160-01-F
