[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36178-36179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17542]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Animal Drugs, Feeds, and Related Products; 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 the change of sponsor for two approved new 
animal drug applications (NADA's) from Danbury Pharmacal, Inc., to 
Phoenix Scientific, Inc.

EFFECTIVE DATE: July 2, 1998.

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: Danbury Pharmacal, Inc., 131 West St., 
Danbury, CT 06810, has informed FDA that it has transferred the 
ownership of and all rights and interests in the approved NADA's 91-818 
and 94-170 (phenylbutazone tablets) to Phoenix Scientific, Inc., 3915 
South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457. The 
agency is amending 21 CFR 510.600(c)(1) and (c)(2) to remove the 
sponsor name for Danbury Pharmacal, Inc., because the firm no longer is 
the holder of any approved NADA's. The agency also is amending 21 CFR 
520.1720a to reflect the change of sponsor.

List of Subjects

 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520

    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 
520 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.


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 ``Danbury Pharmacal, Inc.''; and in 
the table in paragraph (c)(2) by removing the entry for ``000591''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:
    Authority: 21 U.S.C. 360b.


Sec. 520.1720a  [Amended]

    4. Section 520.1720a Phenylbutazone tablets and boluses is amended 
in paragraph (b)(3) by removing the numbers ``000591, 000856, 000864, 
and 015579'' and adding in their place the numbers ``000856, 000864, 
015579, and 059130''.


[[Page 36179]]


    Dated: June 22, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-17542 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F