[Federal Register Volume 69, Number 28 (Wednesday, February 11, 2004)]
[Rules and Regulations]
[Pages 6556-6557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 529 and 556


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 new animal drug 
application (NADA) filed by Alpharma, Inc. The supplemental NADA 
provides for use of oxytetracycline hydrochloride soluble

[[Page 6557]]

powder for skeletal marking of finfish fry and fingerlings by 
immersion.

DATES:  This rule is effective February 11, 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: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 130-435 that 
provides for use of OXYMARINE (oxytetracycline hydrochloride) Soluble 
Powder for skeletal marking of finfish fry and fingerlings by 
immersion. The approval of this supplemental NADA 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 NADA is approved as of December 24, 2003, and 
the regulations are amended in 21 CFR part 529 by adding Sec. 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

21 CFR Part 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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 parts 529 and 
556 are amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
2. Section 529.1660 is added to read as follows:


Sec. 529.1660  Oxytetracycline.

    (a) Specifications. Each gram of powder contains 366 milligrams 
(mg) of oxytetracycline hydrochloride.
    (b) Sponsor. See No. 046573 in Sec. 510.600 of this chapter.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d) Conditions of use in finfish--(1) Amount. Immerse fish in a 
solution containing 200 to 700 mg oxytetracycline hydrochloride 
(buffered) per liter of water for 2 to 6 hours.
    (2) Indications for use. For skeletal marking of finfish fry and 
fingerlings.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 360b, 371.


Sec. 556.500  [Amended]

0
4. Section 556.500 Oxytetracycline is amended in paragraph (b) by 
removing ``catfish, lobster, and salmonids'' and by adding in its place 
``finfish, and lobster''.

    Dated: January 30, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-2894 Filed 2-10-04; 8:45 am]
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