[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
