[Federal Register Volume 60, Number 126 (Friday, June 30, 1995)]
[Rules and Regulations]
[Page 34135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16093]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 510
New Animal Drugs; Change of Sponsor Name and Address
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 a change of sponsor name and address from
DDI Pharmaceuticals, Inc., to OXIS International, Inc.
EFFECTIVE DATE: June 30, 1995.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
SUPPLEMENTARY INFORMATION: DDI Pharmaceuticals, Inc., 518 Logue Ave.,
Mountain View, CA 94043, has informed FDA of a change of sponsor name
and address to OXIS International, Inc., 6040 N. Cutter Circle, suite
317, Portland, OR 97217-3935. Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of
sponsor name and address.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 part 510 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
removing the entry for ``DDI Pharmaceuticals, Inc.,'' and by
alphabetically adding a new entry for ``OXIS International, Inc.,'' and
in the table in paragraph (c)(2) in the entry ``024991'' by revising
the sponsor name and address 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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* * * * *
OXIS International, Inc., 6040 N. 024991
Cutter Circle, suite 317,
Portland, OR 97217-3935.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
024991............................. OXIS International, Inc., 6040 N.
Cutter Circle, suite 317,
Portland, OR 97217-3935
* * * * *
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Dated: June 23, 1995.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 95-16093 Filed 6-29-95; 8:45 am]
BILLING CODE 4160-01-F
