[Federal Register Volume 71, Number 246 (Friday, December 22, 2006)]
[Rules and Regulations]
[Pages 76901-76902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21951]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected].

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.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
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