[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
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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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(2) * * *
----------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
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* * * * * *
*
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
