[Federal Register: December 10, 2003 (Volume 68, Number 237)]
[Rules and Regulations]
[Page 68723]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de03-3]
=======================================================================
-----------------------------------------------------------------------
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: lluther@cvm.fda.gov.
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