[Federal Register Volume 69, Number 131 (Friday, July 9, 2004)]
[Rules and Regulations]
[Page 41427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15568]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 524


New Animal Drugs; 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 a change of sponsor for four new animal 
drug applications (NADAs) from PM Resources, Inc., to Virbac AH, Inc.

DATES: This rule is effective July 9, 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: PM Resources, Inc., 13001 St. Charles Rock 
Rd., Bridgeton, MO 63044, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following four 
approved NADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 
76137:

------------------------------------------------------------------------
                            21 CFR
    Application No.         Section                Trade Name
------------------------------------------------------------------------
NADA 007-076               520.2325a   SULFA-NOX (sulfaquinoxaline)
                                        Liquid
------------------------------------------------------------------------
NADA 008-244               520.2325a   SULFA-NOX (sulfaquinoxaline)
                                        Concentrate
------------------------------------------------------------------------
NADA 043-215                 524.900   PURINA Grub-Kill (famphur)
------------------------------------------------------------------------
NADA 092-150                520.2045   PURINA Horse & Colt Wormer
                                        (pyrantel tartrate)
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.2045, 520.2325a, and 524.900 to reflect the transfer of ownership.
    Following these changes of sponsorship, PM Resources, Inc., is no 
longer the sponsor of an approved application. Accordingly, Sec.  
510.600(c) is being amended to remove the entries for PM Resources, 
Inc.
    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 Parts 520 and 524

    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, 
520, and 524 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 ``PM Resources, Inc.'' and in the table in 
paragraph (c)(2) by removing the entry for ``060594''.

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.  520.2045  [Amended]

0
4. Section 520.2045 is amended in paragraph (b)(2) by removing 
``060594'' and by adding in its place ``051311''.


Sec.  520.2325a  [Amended]

0
5. Section 520.2325a is amended in paragraph (a)(2) by removing 
``060594'' and by adding in its place ``051311''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec.  524.900  [Amended]

0
7. Section 524.900 is amended in paragraph (c) by removing ``060594'' 
and by adding in its place ``051311''.

    Dated: June 18, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-15568 Filed 7-8-04; 8:45 am]
BILLING CODE 4160-01-S