[Federal Register Volume 62, Number 171 (Thursday, September 4, 1997)]
[Rules and Regulations]
[Page 46668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23372]
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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.
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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 Med-Pharmex, Inc. The ANADA provides for
oral use of tetracycline hydrochloride soluble powder in the drinking
water of swine and calves 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: September 4, 1997.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center For
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767-1861, filed ANADA 200-234, which provides for oral use
of tetracycline hydrochloride soluble powder in the drinking water of
calves, swine, chickens, and turkeys, 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., Actinobacillus 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; and (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 Med-Pharmex's ANADA 200-234 tetracycline hydrochloride
soluble powder is as a generic copy of Fermenta's NADA 65-496
tetracycline hydrochloride soluble powder. ANADA 200-234 is approved as
of July 22, 1997, and the regulations are amended in 21 CFR
520.2345d(a)(1) 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 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 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).
Sec. 520.2345d [Amended]
2. Section 520.2345d Tetracycline hydrochloride soluble powder is
amended in paragraph (a)(1) by removing ``047864, 000010, 057561, and
059130'' and adding in its place ``047864, 051259, 054273, 057561, and
059130''.
Dated: August 22, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-23372 Filed 9-3-97; 8:45 am]
BILLING CODE 4160-01-F
