[Federal Register: December 5, 2002 (Volume 67, Number 234)]
[Rules and Regulations]
[Page 72366-72367]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de02-4]
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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 original abbreviated new
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd.
The ANADA provides for the administration
[[Page 72367]]
of an oxytetracycline injectable solution to cattle and swine for the
treatment of various bacterial diseases.
DATES: This rule is effective December 5, 2002.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed original ANADA 200-306 that
provides for the use of Oxytetracycline Injection (200 milligrams per
milliliter (mg/mL)) as a treatment for various bacterial diseases in
cattle and swine. Norbrook's Oxytetracycline Injection (200 mg/mL) is
approved as a generic copy of Pfizer's LIQUAMYCIN LA-200, approved
under NADA 113-232. The application is approved as of June 18, 2002,
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 Dockets Management Branch (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 Subjects in 21 CFR Part 522
Animal drugs.
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
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1660 [Amended]
2. Section 522.1660 Oxytetracycline injection is amended in
paragraph (b) by removing ``Sponsor'' and by adding in its place
``Sponsors'', and by numerically adding ``055529''; in paragraph
(d)(1)(iii) in the second and ninth sentences by numerically adding
``055529''; and in paragraph (d)(2)(iii) in the third sentence by
removing ``when provided by 000010, 000069, 011722, 053389, 059130, and
061623''.
Dated: November 15, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-30782 Filed 12-4-02; 8:45 am]
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