[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]



=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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<Register> 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