[Federal Register Volume 62, Number 82 (Tuesday, April 29, 1997)]
[Rules and Regulations]
[Page 23128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10979]


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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; 
Sulfadimethoxine Injection

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 Phoenix Scientific, Inc. The ANADA 
provides for use of sulfadimethoxine injection in cattle for treatment 
of certain bacterial infections.

EFFECTIVE DATE: April 29, 1997.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center For 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
177, which provides for intravenous use of sulfadimethoxine injection 
in cattle for treatment of bovine respiratory disease (shipping fever 
complex), bacterial pneumonia, calf diphtheria, and foot-rot.
    Approval of Phoenix's ANADA 200-177 for sulfadimethoxine injection 
is as a generic copy of Pfizer's NADA 41-245 for Albon 
(sulfadimethoxine) Injection 40 percent. The ANADA is approved as of 
March 13, 1997, and the regulations are amended by adding new 21 CFR 
522.2220(a)(2)(iii) to reflect the approval. 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 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 Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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.

List of Subjects in 21 CFR Part 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

    2. Section 522.2220 is amended by adding new paragraph (a)(2)(iii) 
to read as follows:

Sec. 522.2220  Sulfadimethoxine injection.

    (a) * * *
    (2) * * *
    (iii) See No. 059130 for use as in paragraph (a)(3)(iii) of this 
section.
* * * * *

    Dated: April 8, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-10979 Filed 4-28-97; 8:45 am]
BILLING CODE 4160-01-F