[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
