[Federal Register: February 11, 2004 (Volume 69, Number 28)]
[Rules and Regulations]
[Page 6556-6557]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe04-26]
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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:
jgotthar@cvm.fda.gov.
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.
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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 parts 529 and
556 are 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 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
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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]
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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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