[Federal Register Volume 64, Number 172 (Tuesday, September 7, 1999)]
[Rules and Regulations]
[Pages 48543-48544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23131]
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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 a supplemental abbreviated new
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The
supplemental ANADA provides for an additional package size of
oxytetracycline hydrochloride soluble powder to be used to make a
medicated drinking water for chickens, turkeys, cattle, swine, and
sheep for control and/or treatment of various bacterial diseases.
EFFECTIVE DATE: September 7, 1999.
FOR FURTHER INFORMATION CONTACT: William G. Marnane, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6966.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed
supplemental ANADA 200-146 that provides for use of 6.4 ounce (181.5
gram (g)) packet of oxytetracycline hydrochloride soluble powder (10 g
oxytetracycline hydrochloride per packet) for use in making medicated
drinking water for chickens, turkeys, cattle, swine, and sheep for
treatment and/or control of various bacterial diseases. The
supplemental ANADA is approved as of July 26, 1999, and the regulations
are amended in 21 CFR 520.1660d(a)(7) to reflect the approval.
This supplemental ANADA concerns an additional packet size of
product to be used as currently approved. The safety and effectiveness
of the product does not change. A freedom of information summary as
described in 21 CFR part 20 and 514.11(e)(2)(ii) is not required.
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.
[[Page 48544]]
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: 21 U.S.C. 360b.
Sec. 520.1660d [Amended]
2. Section 520.1660d Oxytetracycline hydrochloride soluble powder
is amended in paragraphs (a)(1) and (a)(2) by removing the semicolons
at the end of the paragraphs and by adding periods in their places, and
in paragraph (a)(7) by adding at the beginning of the first
parenthetical phrase the words ``packet: 6.4 oz.;''.
Dated: August 24, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 99-23131 Filed 9-3-99; 8:45 am]
BILLING CODE 4160-01-F
