[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Rules and Regulations]
[Pages 45158-45159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15761]


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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; 
Ampicillin Sodium

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 G. C. Hanford Manufacturing Co. The ANADA 
provides for the use of ampicillin sodium powder in aqueous solution by 
injection in horses for the treatment of various bacterial infections.

DATES: This rule is effective August 13, 2007.

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: G. C. Hanford Manufacturing Co., P.O. Box 
1017, Syracuse, NY 13201, filed ANADA 200-335 that provides for use of 
ampicillin sodium as a constituted solution by injection in horses for 
the treatment of various bacterial infections. G. C. Hanford 
Manufacturing Co.'s Ampicillin Sodium is approved as a generic copy of 
Pfizer, Inc.'s, AMP-EQUINE, approved under NADA 55-084. The ANADA is 
approved as of July 12, 2007, and the regulations are amended in 21 CFR 
522.90c 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.

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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 AND INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

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2. Revise Sec.  522.90c to read as follows:


Sec.  522.90c  Ampicillin sodium.

    (a) Specifications. Each milliliter of aqueous solution constituted 
from ampicillin sodium powder contains 300 milligrams (mg) ampicillin 
equivalents.
    (b) Sponsors. See Nos. 000069 and 010515 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in horses--(1) Amount: 3 mg per pound of body 
weight twice daily by intravenous or intramuscular injection.
    (2) Indications for use. For the treatment of respiratory tract 
infections (pneumonia and strangles) due to

[[Page 45159]]

Staphylococcus spp., Streptococcus spp. (including S. equi), 
Escherichia coli, and Proteus mirabilis, and skin and soft tissue 
infections (abscesses and wounds) due to Staphylococcus spp., 
Streptococcus spp., E. coli, and P. mirabilis, when caused by 
susceptible organisms.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: August 1, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-15761 Filed 8-10-07; 8:45 am]
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