[Federal Register Volume 69, Number 110 (Tuesday, June 8, 2004)]
[Rules and Regulations]
[Page 31878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12840]


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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: 
[email protected].

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:

------------------------------------------------------------------------
                                 21 CFR
      Application No.           Section              Trade Name
------------------------------------------------------------------------
NADA 102-942                    520.580     PULVEX Multipurpose Worm
                                             Caps
NADA 091-260                    520.1804    PULVEX Worm Caps
------------------------------------------------------------------------

    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

0
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]

0
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

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.580  [Amended]

0
4. Section 520.580 is amended in paragraph (b)(1) by removing 
``050906'' and by adding in its place ``051311''.


Sec.  520.1804  [Amended]

0
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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