[Federal Register Volume 69, Number 150 (Thursday, August 5, 2004)]
[Rules and Regulations]
[Pages 47361-47362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17878]



[[Page 47361]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 524


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 one new animal drug 
application (NADA) from Chemdex, Inc., to Sparhawk Laboratories, Inc., 
and one NADA and two abbreviated new animal drug applications (ANADAs) 
from Veterinary Laboratories, Inc., to Sparhawk Laboratories, Inc.

DATES: This rule is effective August 5, 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: Chemdex, Inc., 12340 Santa Fe Trail Dr., 
Lenexa, KS 66215, has informed FDA that it has transferred ownership 
of, and all rights and interest in, the following approved NADA to 
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 
66215:

------------------------------------------------------------------------
                             21 CFR
    Application No.         Section                Trade Name
------------------------------------------------------------------------
NADA 138-255                522.1183   Iron Hydrogenated Dextran
                                        Injection
------------------------------------------------------------------------

    Veterinary Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 
66215, has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following approved NADA and two approved 
ANADAs to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., 
Lenexa, KS 66215:

------------------------------------------------------------------------
                             21 CFR
    Application No.         Section                Trade Name
------------------------------------------------------------------------
NADA 138-657               524.1580b   Nitrofurazone Ointment
------------------------------------------------------------------------
ANADA 200-315               522.1260   Lincomycin Injection 25;
                                        Lincomycin Injection 100;
                                       Lincomycin Injection 300
------------------------------------------------------------------------
ANADA 200-324                522.540   Dexamethasone Injection 2
                                        milligrams/milliliters
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
522.540, 522.1183, 522.1260, and 524.1580b to reflect the transfer of 
ownership.
    Following these changes of sponsorship, Chemdex, Inc., and 
Veterinary Laboratories, Inc., are no longer the sponsor of an approved 
application. Accordingly, the agency is amending 21 CFR 510.600(c) to 
remove the entries for Chemdex, Inc., and Veterinary Laboratories, 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 522 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, 
522, 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.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entries for ``Chemdex, Inc.'' and ``Veterinary 
Laboratories, Inc.'' and by alphabetically adding an entry for 
``Sparhawk Laboratories, Inc.''; and in the table in paragraph (c)(2) 
by removing the entries for ``017287'' and ``000857'' and by 
numerically adding an entry for ``058005'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
           Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Sparhawk Laboratories, Inc., 12340 Santa Fe  058005
 Trail Dr., Lenexa, KS 66215
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
058005                        Sparhawk Laboratories, Inc., 12340 Santa
                               Fe Trail Dr., Lenexa, KS 66215
                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.540  [Amended]

0
4. Section 522.540 is amended in paragraph (a)(2)(ii) by removing 
``000857'' and by adding in its place ``058005''.


Sec.  522.1183  [Amended]

0
5. Section 522.1183 is amended in paragraph (e)(1) by removing 
``017287'' and by adding in its place ``058005''.


Sec.  522.1260  [Amended]

0
6. Section 522.1260 is amended in paragraph (b)(2) by removing 
``000857'' and by adding in its place ``058005''.

[[Page 47362]]

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

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

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

0
8. Section 524.1580b is amended by revising paragraph (b) to read as 
follows:


Sec.  524.1580b  Nitrofurazone ointment.

* * * * *
    (b) Sponsor. For use on dogs, cats, or horses, see Nos. 000010, 
000069, 023851, 050749, 051259, 058005, and 061623 in Sec.  510.600(c) 
of this chapter. For use on dogs and horses, see No. 017135 in Sec.  
510.600(c) of this chapter. For use on horses, see No. 017153 in Sec.  
510.600(c) of this chapter.
* * * * *

    Dated: June 23, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-17878 Filed 8-4-04; 8:45 am]
BILLING CODE 4160-01-S