[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
