[Federal Register: June 8, 2004 (Volume 69, Number 110)]
[Rules and Regulations]
[Page 31878]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn04-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
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 two approved new
animal drug applications (NADAs) from Zema Corp. to Virbac AH, Inc.
DATES: This rule is effective June 8, 2004.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.gov.
SUPPLEMENTARY INFORMATION: Zema Corp., P.O. Box 12803, Research
Triangle Park, Durham, NC 27709, has informed FDA that it has
transferred ownership of, and all rights and interest in, the following
two approved NADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth,
TX 76137:
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21 CFR
Application No. Section Trade Name
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NADA 102-942 520.580 PULVEX Multipurpose Worm
Caps
NADA 091-260 520.1804 PULVEX Worm Caps
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Accordingly, the agency is amending the regulations in 21 CFR
520.580 and 520.1804 to reflect the transfer of ownership.
Following these changes of sponsorship, Zema Corp. is no longer the
sponsor of an approved application. Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to remove the entries for Zema
Corp.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
0
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
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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]
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2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entry for ``Zema Corp.'' and in the table in paragraph
(c)(2) by removing the entry for ``050906''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
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3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.580 [Amended]
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4. Section 520.580 is amended in paragraph (b)(1) by removing
``050906'' and by adding in its place ``051311''.
Sec. 520.1804 [Amended]
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5. Section 520.1804 is amended in paragraph (b) by removing ``050906''
and by adding in its place ``051311''.
Dated: May 19, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 04-12840 Filed 6-7-04; 8:45 am]
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