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Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin

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 [Federal Register: December 22, 2006 (Volume 71, Number 246)]
[Rules and Regulations]
[Page 76901-76902]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de06-3]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin

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 Sparhawk Laboratories, Inc. The ANADA
provides for use of a gentamicin sulfate injectable solution in piglets
for treatment of porcine colibacillosis.

DATES: This rule is effective December 22, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV 104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe
Trail Dr., Lenexa, KS 66215, filed ANADA 200-394 for the use of
Gentamicin Sulfate Injection in piglets up to 3 days old for treatment
of porcine colibacillosis caused by strains of Escherichia coli
sensitive to gentamicin. Sparhawk Laboratories, Inc.'s Gentamicin
Sulfate Injection is approved as a generic copy of Schering-Plough
Animal Health Corp.'s GARACIN Piglet Injection, approved under NADA
103-037. The ANADA is approved as of November 17, 2006, and the
regulations in 21 CFR 522.1044 are amended to reflect the approval and
a current format. The basis of approval is discussed in the freedom of
information summary.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

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: 21 U.S.C. 360b.

? 2. In Sec.  522.1044, revise the section heading and paragraphs (a) and
(b) to read as follows:

Sec.  522.1044  Gentamicin.

    (a) Specifications. Each milliliter of solution contains gentamicin
sulfate equivalent to 5, 50, or 100 milligrams (mg) gentamicin.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
use as in paragraph (d) of this section.
    (1) No. 000061 for use of 5 mg per milliliter (/mL) solution in
swine as in paragraph (d)(4), 50 mg/mL solution in dogs and cats as in
paragraph (d)(1), 50 mg/mL and 100 mg/mL solution in chickens and
turkeys as in paragraphs (d)(2) and (d)(3) of this section.

[[Page 76902]]

    (2) No. 058005 for use of 5 mg/mL solution in swine as in paragraph
(d)(4) of this section.
    (3) No. 000010 for use of 50 mg/mL solution in dogs as in paragraph
(d)(5) of this section.
    (4) No. 059130 for use of 100 mg/mL solution in turkeys as in
paragraph (d)(2) and in chickens as in paragraph (d)(3) of this section.
* * * * *

    Dated: December 13, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-21951 Filed 12-21-06; 8:45 am]
BILLING CODE 4160-01-S

 
 

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