[Federal Register Volume 63, Number 32 (Wednesday, February 18, 1998)]
[Rules and Regulations]
[Pages 8121-8122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3983]


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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.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by 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, filed ANADA 
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 (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.

 * * * * *
    (c) * * *
    (1) * * *

                                                                                                                
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                 Firm name and address                                      Drug labeler code                   
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Rhone-Poulenc Chemicals, Ltd., P.O. Box 46, St. Andrews  059258                                                 
 Rd., Avonmouth, Bristol BS11 9YF, England, UK                                                                  
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
----------------------------------------------------------------------------------------------------------------

    (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. 98-3983 Filed 2-17-98; 8:45 am]
BILLING CODE 4160-01-F