[Federal Register Volume 60, Number 51 (Thursday, March 16, 1995)]
[Rules and Regulations]
[Page 14217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 Sanofi Animal Health, Inc. The ANADA
provides for the use of a generic neomycin sulfate soluble powder
administered orally in drinking water or in milk for the treatment and
control of colibacillosis in cattle (excluding veal calves), swine,
sheep, and goats.
EFFECTIVE DATE: March 16, 1995.
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: Sanofi Animal Health, Inc., 7101 College
Blvd., suite 610, Overland Park, KS 66210, filed ANADA 200-050, which
provides for the oral use of neomycin sulfate soluble powder in
drinking water or milk for cattle (excluding veal calves), swine,
sheep, and goats for the treatment and control of colibacillosis
(bacterial scours) caused by Escherichia coli susceptible to neomycin
sulfate.
Approval of ANADA 200-050 is as a generic copy of The Upjohn's
approved NADA 11-315 for Neomix 325 soluble powder. The ANADA
is approved as of February 15, 1995, and the regulations are amended by
revising Sec. 520.1484(b) (21 CFR 520.1484(b)) 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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) to read as
follows:
Sec. 520.1484 Neomycin sulfate soluble powder.
* * * * *
(b) Sponsors. See Nos. 000009, 000069, 050604, and 059130 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: March 8, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-6530 Filed 3-15-95; 8:45 am]
BILLING CODE 4160-01-F
