[Federal Register Volume 69, Number 204 (Friday, October 22, 2004)]
[Rules and Regulations]
[Page 61999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


Certain Other Dosage Form New Animal Drugs; Oxytetracycline

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 use of oxytetracycline hydrochloride 
soluble powder for skeletal marking of finfish fry and fingerlings by 
immersion.

DATES: This rule is effective October 22, 2004.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-247 
that provides for use of Oxytetracycline HCl Soluble Powder-343 for 
skeletal marking of finfish fry and fingerlings by immersion. The 
approval of this supplemental ANADA relied on publicly available safety 
and effectiveness data contained in Public Master File (PMF) 5667 which 
were compiled under National Research Support Project 7 (NRSP-7), a 
national agricultural research program for obtaining clearances for use 
of new drugs in minor animal species and for special uses. The 
supplemental ANADA is approved as of September 15, 2004, and the 
regulations are amended in 21 CFR 529.1660 to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    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.
    FDA has determined under 21 CFR 25.33(d)(4) 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 529

    Animal drugs.

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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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


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2. Section 529.1660 is amended by revising paragraphs (a) and (b) to 
read as follows:


Sec.  529.1660  Oxytetracycline.

    (a) Specifications--(1) Each gram of powder contains 366 milligrams 
(mg) oxytetracycline hydrochloride.
    (2) Each gram of powder contains 753 mg oxytetracycline 
hydrochloride.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use of products described in paragraph (a) of this section as in 
paragraph (d) of this section.
    (1) No. 046573 for use of product described in paragraph (a)(1) of 
this section.
    (2) No. 059130 for use of product described in paragraph (a)(2) of 
this section.
* * * * *

    Dated: October 14, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-23686 Filed 10-21-04; 8:45 am]
BILLING CODE 4160-01-S