[Federal Register Volume 62, Number 147 (Thursday, July 31, 1997)]
[Rules and Regulations]
[Pages 40930-40931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20249]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor
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 for 46 new animal drug
applications (NADA's) from Solvay Animal Health, Inc., to Fort Dodge
Animal Health, A Division of American Cyanamid Co.
EFFECTIVE DATE: July 31, 1997.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0213.
SUPPLEMENTARY INFORMATION: Solvay Animal Health, Inc., 1201 Northland
Dr., Mendota Heights, MN 55120, has informed FDA that it has
transferred the ownership of, and all rights and interests in, the
following approved NADA's to Fort Dodge Animal Health, A Division of
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:
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NADA No. Drug Name
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006-417................................ Recovr
006-103................................ Follutein
006-707................................ Sulquin 6-50
008-274................................ Pig Scour Tablets
009-035................................ Ophtaine
011-141................................ Unistat-2
011-482................................ Vetame Tabs and Injection
011-879................................ Rubfrafer Injection
012-198................................ Vetalog Parenteral
012-258................................ Panalog Ointment (Solvaderm)
013-624................................ Vetalog Tabs
014-250................................ Novastat
031-448................................ Rheaform Bolus
031-553................................ Esb3 Powder & Solution
032-319................................ Furox Aerosol Spray
032-738................................ Pacitran Soluble
033-127................................ Vetisulid Bolus
033-318................................ Vetisulid Injectable
033-319................................ Vetisulid Tabs
033-373................................ Vetisulid Powder
034-536................................ Aklomix
034-537................................ Novastat-3
034-705................................ Equipoise
035-388................................ Novastat-W
039-666................................ Unistat-3
040-181................................ Vetisulid Oral Suspension
046-146................................ Vetalog Cream
046-147................................ Dirocide Syrup
049-892................................ Spanbolet II
055-060................................ Potassium G penicillin
055-064................................ Redicillin (Princillin)
055-066................................ Redicillin (Princillin)
055-071................................ Redicillin (Princillin)
065-130................................ Crystaline Pro Penicillin
065-174................................ Crysticillin 300 A.S. Vet
065-410................................ Tetra-Sal Soluble
091-192................................ Renografin 76
091-240................................ Renovist
091-327................................ Gastrogratin
093-512................................ Dirocide Tabs
096-676................................ Panalog Cream
099-388................................ Vetalog Oral Powder
126-232................................ Calfspan
131-808................................ Dirocide Syrup
[[Page 40931]]
139-913................................ Equron
140-909................................ Sulka-S-Bolus
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Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) to reflect the change of sponsor. The drug
labeler code assigned to Solvay Animal Health is being retained as the
drug labeler code for the new sponsor.
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).
Sec. 510.600 [Amended]
2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) by removing the entry for ``Solvay Animal Health, Inc.'' and by
alphabetically adding a new entry for ``Fort Dodge Animal Health, A
Division of American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA
50501'' and in the table in paragraph (c)(2) in the entry for
``053501'' by removing the sponsor name and address ``Solvay Animal
Health, Inc., 1201 Northland Dr., Mendota Heights, MN 55120'' and
adding in its place ``Fort Dodge Animal Health, A Division of American
Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501''.
Dated: July 22, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-20249 Filed 7-30-97; 8:45 am]
BILLING CODE 4160-01-F