Federal Register: December 24, 2002 (Volume 67, Number 247)
DOCID: FR Doc 02-32276
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
CFR Citation: 21 CFR Part 522
ACTION: Animal drugs, feeds, and related products:
DOCUMENT ACTION: Final rule.
Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection
DATES: This rule is effective December 24, 2002.
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 Boehringer Ingelheim Vetmedica, Inc. The supplemental ANADA provides for the administration of an oxytetracycline injectable solution to lactating dairy cattle.
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St. Joseph, MO 645062002, filed a supplement to approved ANADA 200008 that provides for the use of BIOMYCIN 200 (oxytetracycline injection) and OXYTET 200 (oxytetracycline injection) as treatments for various bacterial diseases in cattle and swine. The supplemental ANADA provides for the administration of these oxytetracycline injectable solutions to lactating dairy cattle. The supplemental application is approved as of September 3, 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 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 (HFA305), 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. 801808.
List of Subjects in 21 CFR Part 522
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 522IMPLANTATION 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 (d)(1)(iii) by removing in the eighth sentence ``000010,
059130, and 061623'' and adding in its place``059130 and 061623'', and
by removing in the ninth sentence ``For sponsors'' and adding in its place ``For sponsors 000010,''.
Dated: December 4, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 0232276 Filed 122302; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Julia W. Punderson, Center for
Veterinary Medicine (HFV133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018277570, email: