[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Rules and Regulations]
[Pages 29985-29986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13828]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Gentamicin Sulfate Injection
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 use of gentamicin sultate injection in day-old chickens
for the prevention of early mortality caused by Escherichia coli,
Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to
gentamicin sulfate.
EFFECTIVE DATE: June 7, 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., Overland Park, KS 66210, has filed ANADA 200-147, which provides
for use of gentamicin sulfate injection in day-old chickens for the
prevention of early mortality caused by E. coli, S. typhimurium, and P.
aeruginosa susceptible to gentamicin sulfate.
Sanofi Animal Health, Inc.'s, ANADA 200-147 for gentamicin sulfate
injection (100 milligrams of gentamicin per milliliter (mg/mL)
solution) is approved as a generic copy of Schering-Plough Animal
Health's NADA 101-862 for Garasol (50 and 100 mg of gentamicin/mL
solution) injection. The ANADA is approved as of April 10, 1995, and
the regulations are amended in Sec. 522.1044 (21 CFR 522.1044) to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
In addition, the regulation failed to reflect that Schering-
Plough's NADA 101-862 was approved for use of 100 mg of gentamicin/mL
as well as 50 mg of gentamicin/mL injection. At this time,
Sec. 522.1044 is amended to indicate that both concentrations of the
drug are approved for use in day-old chickens.
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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 522.1044 is amended by revising paragraphs (a) and
(b)(1) and by adding new paragraph (b)(4) to read as follows:
Sec. 522.1044 Gentamicin sulfate injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains gentamicin sulfate equivalent to either 5, 50, or 100
milligrams of gentamicin.
(b) Sponsors. (1) See No. 000061 in Sec. 510.600(c) of this chapter
for use of 5 milligrams-per-milliliter solution in swine as in
paragraph (d)(4) of this section, for use of 50 milligrams-per-solution
in dogs, cats, and chickens as in paragraph (d)(1) and (d)(3) of this
section, for use of 100 milligrams-per- [[Page 29986]] milliliter
solution in chickens as in paragraph (d)(3) of this section.
* * * * *
(4) See No. 050604 for use of 100 milligrams-per-milliliter
solution in chickens as in paragraph (d)(3) of this section.
* * * * *
Dated: May 22, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13828 Filed 6-6-95; 8:45 am]
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