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

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Federal Register: February 18, 1998 (Volume 63, Number 32)Rules and RegulationsPage 8121-8122From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr18fe98-24

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

Certain Other Dosage Form New Animal Drugs; Isoflurane

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 Rhone-Poulenc Chemicals, Ltd. The ANADA provides for use of isoflurane, USP, as an inhalant for induction and maintenance of general anesthesia in horses and dogs.

EFFECTIVE DATE: February 18, 1998. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center For Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Rhone-Poulenc Chemicals, Ltd., P.O. Box 46, St. Andrew's Rd., Avonmouth, Bristol BS11 9YF, England, UK, filedANADA 200-237 that provides for inhalant use of isoflurane, USP, for induction and maintenance of general anesthesia in horses and dogs. The drug is limited to use by or on the order of a licensed veterinarian.

Approval of ANADA 200-237 for Rhone-Poulenc Chemicals, Ltd.'s isoflurane is as a generic copy of Ohmeda Pharmaceutical Products Division, Inc.'s NADA 135-773 AErrane<Register> (isoflurane, USP). The ANADA is approved as of December 19, 1997, and the regulations are amended in 21 CFR 529.1186(b) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

Also, the sponsor has not been previously included in the list of sponsors of approved applications in Sec. 510.600 (21 CFR 510.600). The regulations are amended in Sec. 510.600(c)(1) and (c)(2) to reflect the the new sponsor.

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 20855, between 9 a.m. to 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.

[Page 8122]List of Subjects

21 CFR Part 510

Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 529

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 parts 510 and 529 are amended as follows:

PART 510--NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding an entry for ``Rhone-Poulenc Chemicals, Ltd.,'' and in the table in paragraph (c)(2) by numerically adding an entry for ``059258'' to read as follows:

Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

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  (c) * * *

  (1) * * *

Firm name and address

Drug labeler code

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*

*

*

*

*

Rhone-Poulenc Chemicals, Ltd., P.O. Box 46, St. Andrews 059258

Rd., Avonmouth, Bristol BS11 9YF, England, UK

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*

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*

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  (2) * * *

Drug labeler code

Firm name and address

*

*

*

*

*

*

*

059258

Rhone-Poulenc Chemicals, Ltd., P.O. Box 46, St. Andrews Rd., Avonmouth, Bristol BS11 9YF, England, UK.

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PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 529 continues to read as follows:

Authority: 21 U.S.C. 360b.

4. Section 529.1186 is amended by revising paragraph (b) to read as follows:

Sec. 529.1186 Isoflurane.

* * * * *

  (b) Sponsors. See Nos. 000074, 010019, 012164, and 059258 in Sec. 510.600(c) of this chapter. * * * * *

Dated: January 30, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

FR Doc. 98-3983Filed2-17-98; 8:45 amBILLING CODE 4160-01-F

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