Rules and Regulations. Final rule
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/register/2001/03/08/01-5683A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Clindamycin Hydrochloride Liquid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. 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 oral use of clindamycin hydrochloride liquid for treatment of soft tissue and dental infections in cats. DATES: This rule is effective March 8, 2001. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0212. SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed a supplement to approved ANADA 200-193 for Clindamycin Hydrochloride Oral Liquid. The supplemental ANADA provides for use of clindamycin hydrochloride liquid for treatment of soft tissue and dental infections in cats caused by or associated with susceptible strains of certain bacterial species. The supplemental application is approved as of December 27, 2000, and the regulations are amended in 21 CFR 520.447 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 (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 520 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 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. § 520.447 [Amended] 2. Section 520.447 *Clindamycin hydrochloride liquid* is amended in paragraph
(b)in the first sentence by removing “No. 000009” and adding in its place “Nos. 000009 and 059130” and by removing the second sentence. Dated: January 30, 2001. Claire M. Lathers, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 01-5683 Filed 3-7-01; 8:45 am]
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- 21 CFR 520
- 21 CFR 20
- 5 USC 801-808
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