[Federal Register Volume 68, Number 237 (Wednesday, December 10, 2003)]
[Rules and Regulations]
[Page 68723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30642]


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

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for use of oxytetracycline hydrochloride 
soluble powder in honeybees for the control and treatment of foulbrood, 
and in swine drinking water with a reduction in preslaughter withdrawal 
time to zero days.

DATES: This rule is effective December 10, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed a supplement to ANADA 200-247 
that provides for use of Oxytetracycline HCl Soluble Powder-343 for 
making medicated drinking water for the treatment of various bacterial 
diseases of livestock. The supplemental ANADA provides for use of 
oxytetracycline hydrochloride soluble powder in honeybees for the 
control and treatment of foulbrood, and in swine drinking water with a 
reduction in preslaughter withdrawal time to zero days. A new container 
size, a 4.78-ounce packet, is also being approved. The supplemental 
ANADA is approved as of November 12, 2003, and the regulations are 
amended in 21 CFR 520.1660d to reflect the approval.
    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 Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Section 520.1660d is amended in the third sentence in paragraph 
(d)(1)(iii)(C) by removing ``withdraw 5 days prior to slaughter those 
products sponsored by No. 059130 and zero days those products sponsored 
by No. 000069'' and by adding in its place ``withdraw zero days prior 
to slaughter those products sponsored by Nos. 000069 and 059130'' and 
by revising paragraphs (a)(7) and (b)(5) to read as follows:


Sec.  520.1660d  Oxytetracycline hydrochloride soluble powder.

    (a) * * *
* * * * *
    (7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 
4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder 
contains 1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb).
* * * * *
    (b) * * *
* * * * *
    (5) No. 059130 for use of OTC HCl concentration in paragraph (a)(7) 
of this section in chickens, turkeys, swine, cattle, sheep, and 
honeybees.
* * * * *

    Dated: November 21, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-30642 Filed 12-9-03; 8:45 am]
BILLING CODE 4160-01-S