[Federal Register Volume 59, Number 166 (Monday, August 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21158]
[[Page Unknown]]
[Federal Register: August 29, 1994]
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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 Inhalon Pharmaceuticals, Inc. The ANADA
provides for the use of a generic isoflurane for induction and
maintenance of anesthesia in horses and dogs.
EFFECTIVE DATE: August 29, 1994.
FOR FURTHER INFORMATION CONTACT:
Larry D. Rollins, Center for Veterinary Medicine (HFV-110), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-
1612.
SUPPLEMENTARY INFORMATION: Inhalon Pharmaceuticals, Inc., P.O. Box
21170, Lehigh Valley, PA 18002, filed ANADA 200-141, which provides for
the use of a generic isoflurane (99.9 percent isoflurane solution) for
induction and maintenance of anesthesia in horses and dogs.
Inhalon Pharmaceuticals' ANADA 200-141 for isoflurane is approved
as a generic copy of Anaquest's NADA 135-773 for isoflurane. The ANADA
is approved as of July 26, 1994, and the regulations are amended in 21
CFR 529.1186 to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
In addition, Inhalon Pharmaceuticals, Inc., has not previously been
listed in 21 CFR 510.600 (c)(1) and (c)(2) 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 is 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
adding alphabetically a new entry for ``Inhalon Pharmaceuticals, Inc.''
and in the table in paragraph (c)(2) by adding numerically a new entry
for ``060307'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug
Firm name and address labeler
code
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*****
Inhalon Pharmaceuticals, Inc., P.O. Box 21170, Lehigh Valley,
PA 18002..................................................... 060307
*****
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(2) * * *
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Drug labeler
code Firm name and address
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*****
060307....... Inhalon Pharmaceuticals, Inc., P.O. Box 21170, Lehigh
Valley, PA 18002
*****
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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).
Sec. 529.1186 [Amended]
2. Section 529.1186 Isoflurane is amended in paragraph (b) by
removing the phrase ``Nos. 010019 and 000074'' and adding in its place
``Nos. 010019, 000074, and 06037''.
Dated: August 19, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-21158 Filed 8-26-94; 8:45 am]
BILLING CODE 4160-01-M
