Animal drugs, feeds, and related products: New drug applications— Guaifenesin injection,

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Federal Register: May 29, 1998 (Volume 63, Number 103)Rules and RegulationsPage 29352-29353From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr29my98-7

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs; Guaifenesin Injection

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 an abbreviated new animal drug application (ANADA) filedby Phoenix Scientific, Inc. The ANADA provides for intravenous use of guaifenesin injection in horses as a skeletal muscle relaxant.

EFFECTIVE DATE: May 29, 1998. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center For Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filedANADA 200- 230 that provides for intravenous use of guaifenesin injection in horses as a skeletal muscle relaxant.

Approval of Phoenix Scientific, Inc.'s, ANADA 200-230 for guaifenesin injection is as a generic copy of Summit Hill Laboratories' NADA 48-854 for Gecolate (guaifenesin) Injection. The ANADA is approved as of April 8, 1998, and the regulations are amended in 21 CFR 522.1086(b) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, paragraph (c) is redesignated as paragraph (d) and paragraph (c) is reserved.

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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(d)(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.

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. 522.1086 [Amended]

2. Section 522.1086 Guaifenesin injection is amended in paragraph (b) by removing ``No. 037990'' and adding in its place ``Nos. 037990 and 059130'', by redesignating paragraph (c) as paragraph (d), and by reserving paragraph (c).

[Page 29353]

Dated: May 12, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

FR Doc. 98-14183Filed5-28-98; 8:45 amBILLING CODE 4160-01-F

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