[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Rules and Regulations]
[Page 54806]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Oxytetracycline Injection
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 an abbreviated new animal drug
application (ANADA) filed by Agri Laboratories, Ltd. The ANADA provides
for the administration of an oxytetracycline injectable solution to
cattle and swine for the treatment of various bacterial diseases.
DATES: This rule is effective September 19, 2003.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St.
Joseph, MO 64503, filed ANADA 200-128 that provides for the use of
AGRIMYCIN 200 (oxytetracycline) Injection for the treatment of various
bacterial diseases in cattle and swine. Agri Laboratories's AGRIMYCIN-
200 Injection is approved as a generic copy of Pfizer's LIQUAMYCIN LA-
200, approved under NADA 113-232. The ANADA is approved as of June 13,
2003, and the regulations are amended in 21 CFR 522.1660 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.
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 Subject in 21 CFR Part 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1660 [Amended]
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2. Section 522.1660 Oxytetracycline injection is amended in paragraph
(b) by numerically adding ``057561''; and in paragraph (d)(1)(iii) in
the second and ninth sentences by numerically adding ``057561''.
Dated: August 29, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-23942 Filed 9-18-03; 8:45 am]
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