[Federal Register Volume 62, Number 24 (Wednesday, February 5, 1997)]
[Rules and Regulations]
[Pages 5318-5319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2819]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Tetracycline Hydrochloride
Soluble Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 oral use of tetracycline hydrochloride soluble powder in
the drinking water of calves and swine for control and treatment of
certain diseases caused by pathogens susceptible to tetracycline, and
of chickens and turkeys for control of certain diseases caused by
pathogens susceptible to tetracycline.
EFFECTIVE DATE: February 5, 1997.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center For
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
136, which provides for oral use of tetracycline hydrochloride soluble
powder in the drinking water of calves and swine for control and
treatment of certain conditions, and of chickens and turkeys for the
control of certain conditions, as follows: (1) For calves for control
and treatment of bacterial enteritis (scours) caused by Escherichia
coli, and bacterial pneumonia (shipping fever complex) associated with
Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.),
and Klebsiella spp. susceptible to tetracycline; (2) for swine for
control and treatment of bacterial enteritis (scours) caused by E.
coli, and bacterial pneumonia associated with Pasteurella spp., A.
pleuropneumoniae (Hemophilus spp.), and Klebsiella spp. susceptible to
tetracycline; (3) for chickens for control of chronic respiratory
disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and
E. coli; infectious synovitis caused by M. synoviae susceptible to
tetracycline; (4) for turkeys for control of infectious synovitis
caused by M. synoviae and bluecomb (transmissible enteritis or
coronaviral enteritis) complicated by bacterial organisms susceptible
to tetracycline.
Approval of Phoenix's ANADA 200-136 tetracycline hydrochloride
soluble powder is as a generic copy of Fermenta's NADA 65-496
tetracycline hydrochloride soluble powder. ANADA 200-136 is approved as
of December 17, 1996, and the regulations are amended in
Sec. 520.2345d(a)(1) (21 CFR 520.2345d(a)(1)) to reflect the approval.
The basis of approval is discussed in the freedom of information
summary.
In addition, due to enactment of the Generic Animal Drug and Patent
Term Restoration Act of 1988, the paragraph concerning NAS/NRC status
is outdated. Section 520.2345d is amended to remove paragraph (c).
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 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
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:
[[Page 5319]]
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).
Sec. 520.2345d [Amended]
2. Section 520.2345d Tetracycline hydrochloride soluble powder is
amended in paragraph (a)(1) by removing ``047864, 054273, and 057561''
and adding in its place ``047864, 054273, 057561, and 059130'' and by
removing and reserving paragraph (c).
Dated: January 28, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-2819 Filed 2-4-97; 8:45 am]
BILLING CODE 4160-01-F
