[Federal Register: October 22, 2004 (Volume 69, Number 204)]
[Rules and Regulations]
[Page 61999]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc04-5]
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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:
joan.gotthardt@fda.gov.
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