[Federal Register Volume 62, Number 25 (Thursday, February 6, 1997)]
[Rules and Regulations]
[Pages 5525-5526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Amoxicillin Bolus and Soluble 
Powder

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 codify two previously approved supplemental new 
animal drug applications (NADA's) filed by Pfizer, Inc. The 
supplemental NADA's provide for the use of amoxicillin boluses and 
soluble powder in preruminating calves including veal calves.

EFFECTIVE DATE: February 6, 1997.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, is sponsor of NADA 55-087 Amoxi-Bol (amoxicillin 
trihydrate) bolus and NADA 55-088 Amoxi-Sol (amoxicillin 
trihydrate) soluble powder which provide for treatment of bacterial 
enteritis when due to susceptible Escherichia coli in preruminating 
calves including veal calves. Use is by or on the order of a licensed 
veterinarian. These supplemental NADA's were approved on October 7, 
1993, but the regulations were inadvertently not amended at that time 
to reflect these approvals. The regulations are now being amended in 
Secs. 520.88d(d) and 520.88e(d) (21 CFR 520.88d(d) and 520.88e(d)) to 
reflect the approvals. In addition, the term ``nonruminating'' is being 
changed to ``preruminating'' to better describe the type of animal 
being treated.
    The supplemental approvals provided for further clarification of 
the class of animals indicated for treatment. No additional safety or 
effectiveness data were required. Therefore, a freedom of information 
(FOI) summary is not required.

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

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 520.88d is amended by revising the heading for paragraph 
(d), paragraph (d)(2), and the third sentence in paragraph (d)(3) to 
read as follows:

Sec. 520.88d  Amoxicillin trihydrate soluble powder.

* * * * *
    (d) Conditions of use. Preruminating calves including veal calves--
* * * * *
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.

[[Page 5526]]

    (3) * * * For use in preruminating calves including veal calves 
only, not for use in other animals which are raised for food 
production. * * *
    3. Section 520.88e is amended by revising the heading for paragraph 
(d), paragraph (d)(2), and the first sentence in paragraph (d)(3) to 
read as follows:

Sec. 520.88e  Amoxicillin trihydrate boluses.

* * * * *
    (d) Conditions of use. Preruminating calves including veal calves--
* * * * *
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.
    (3) Limitations. For oral use in preruminating calves including 
veal calves only, not for use in other animals which are raised for 
food production. * * *

    Dated: January 27, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation Center for Veterinary 
Medicine
[FR Doc. 97-3015 Filed 2-5-97; 8:45 am]
BILLING CODE 4160-01-F