[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2914-2915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1741]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Oxytetracycline 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 Phoenix Scientific, Inc. The ANADA
provides for the use of a generic oxytetracycline hydrochloride soluble
powder administered orally in drinking water for either control or
control and treatment of certain diseases of chickens, turkeys, swine,
cattle, and sheep.
EFFECTIVE DATE: January 30, 1996.
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
St. Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-146
which provides for use of oxytetracycline hydrochloride soluble powder
in the drinking water of chickens, turkeys, swine, cattle, and sheep.
The medicated drinking water is used as follows: (1) Chickens for
control of infectious synovitis caused by Mycoplasma synoviae, chronic
respiratory disease and air sac infections caused by Mycoplasma
gallisepticum and Escherichia coli, and fowl cholera caused by
Pasteurella multocida; (2) turkeys for control of hexamitiasis caused
by Hexamita meleagridis, infectious synovitis caused by M. synoviae,
and complicating bacterial organisms associated with blue comb
(transmissible enteritis; coronaviral enteritis); (3) swine for control
and treatment of bacterial enteritis caused by E. coli and Salmonella
choleraesuis and bacterial pneumonia caused by P. multocida; (4)
breeding swine for control and treatment of leptospirosis (reducing the
incidence of abortions and shedding of leptospira) caused by Leptospira
pomona; (5) calves, beef cattle, and nonlactating dairy cattle for
control and treatment of bacterial enteritis caused by E. coli and
bacterial pneumonia (shipping fever complex) caused by P. multocida;
and (6) sheep for control and treatment of bacterial enteritis caused
by E. coli and bacterial pneumonia (shipping fever complex) caused by
P. multocida.
- ANADA 200-146 for Phoenix Scientific's oxytetracycline
hydrochloride soluble powder is approved as a generic copy of Pfizer's
Terramycin Soluble Powder which is covered by NADA 8-622. The
ANADA is approved as of December 7, 1995, and the regulations in 21 CFR
520.1660d are amended to reflect the approval. The basis for approval
is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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, rm. 1-23,
12420 Parklawn Dr., 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.
[[Page 2915]]
-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 520.1660d is amended by adding new paragraphs (a)(7)
and (b)(5) to read as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
-(a) * * *
-(7) Each 18.14 grams of powder contains 1 gram of OTC HCl (pail: 2
lb).
-(b) * * *
-(5) No. 059130 for use of OTC HCl concentration in paragraph
(a)(7) of this section in chickens, turkeys, swine, cattle, and sheep.
* * * * * -
Dated: January 3, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-1741 Filed 1-29-96; 8:45 am]
BILLING CODE 4160-01-F
