[Federal Register Volume 60, Number 153 (Wednesday, August 9, 1995)]
[Rules and Regulations]
[Pages 40455-40456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19684]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 529
Animal Drugs, Feeds, and Related Products; 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 Halocarbon Laboratories, Division of
Halocarbon Products Corp. The ANADA provides for use of isoflurane as
an inhalant for induction and maintenance of general anesthesia in
horses and dogs.
EFFECTIVE DATE: August 9, 1995.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center For Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1616.
SUPPLEMENTARY INFORMATION: Halocarbon Laboratories, Division of
Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River
Ridge, NJ 07661, filed ANADA 200-129 which provides for inhalant use of
isoflurane 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 200-129 for Halocarbon Laboratories' isoflurane
is as a generic copy of Anaquest's NADA 135-773 for AErrane
(isoflurane). The ANADA is approved as of June 29, 1995, and the
regulations are amended by revising 21 CFR 529.1186(b) to reflect the
approval. The basis of approval is discussed in the freedom of
information summary. In addition, Halocarbon Laboratories has not been
previously listed in 21 CFR 510.600(c) as sponsor of an approved
application. That section is amended to add entries for the firm.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (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 a new entry for ``Halocarbon Laboratories'' and
in the table in paragraph (c)(2) by numerically adding a new entry for
``012164'' 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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* * * *
* * *
Halocarbon Laboratories, Division of 012164
Halocarbon Products Corp., 887
Kinderkamack Rd., P.O. Box 661, River
Ridge, NJ 07661.
* * * *
* * *
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[[Page 40456]]
(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
012164....................... Halocarbon Laboratories, Division of
Halocarbon Products Corp., 887
Kinderkamack Rd., P.O. Box 661, River
Ridge, NJ 07661.
* * * *
* * *
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PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 529.1186 is amended by revising paragraph (b) to read as
follows:
Sec. 529.1186 Isoflurane.
* * * * *
(b) Sponsors. See Nos. 000074, 010019, and 012164 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: July 31, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-19684 Filed 8-8-95; 8:45 am]
BILLING CODE 4160-01-F
