Document ID: FDA-2011-N-0003-0062
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Gentamicin Sulfate
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Page 4226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1753]

[[Page 4226]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Gentamicin Sulfate

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 original abbreviated new 
animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The 
ANADA provides for use of gentamicin sulfate soluble powder used to 
make medicated drinking water for swine.

DATES: This rule is effective January 27, 2012.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8197, email: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group, Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-494 for use of GENTAMED 
(gentamicin sulfate) Soluble Powder used to make medicated drinking 
water for swine. Cross Vetpharm Group's Gentamicin Soluble Powder is 
approved as a generic copy of GARACIN (gentamicin sulfate) Soluble 
Powder, sponsored by Intervet Inc., under NADA 133-836. The abbreviated 
application is approved as of December 14, 2011, and the regulations 
are amended in 21 CFR 520.1044c to reflect the approval.
    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.
    The Agency has determined under 21 CFR 25.33 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 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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Revise Sec.  520.1044c to read as follows:

Sec.  520.1044c  Gentamicin sulfate powder.

    (a) Specifications. Each gram of powder contains gentamicin sulfate 
equivalent to:
    (1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin.
    (2) 333.3 mg gentamicin.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section as follows:
    (1) No. 000061 for products described in paragraph (a)(1) of this 
section.
    (2) Nos. 057561 and 061623 for product described in paragraph 
(a)(2) of this section.
    (c) Related tolerances. See Sec.  556.300 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water for 3 consecutive days as follows:
    (i) For colibacillosis: Gentamicin sulfate equivalent to 25 mg of 
gentamicin per gallon of drinking water to provide 0.5 mg per pound of 
body weight per day;
    (ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of 
gentamicin per gallon of drinking water to provide 1 mg per pound of 
body weight per day. Treatment may be repeated if dysentery recurs.
    (2) Indications for use. For control and treatment of 
colibacillosis in weanling swine caused by strains of Escherichia coli 
sensitive to gentamicin, and for control and treatment of swine 
dysentery associated with Treponema hyodysenteriae.
    (3) Limitations. For use in swine drinking water only. Do not store 
or offer medicated drinking water in rusty containers since the drug is 
quickly destroyed in such containers. Medicated drinking water should 
be prepared daily and be the sole source of drinking water.
    (4) Withdrawal period. 10 days.

    Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1753 Filed 1-26-12; 8:45 am]
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