[Federal Register Volume 66, Number 53 (Monday, March 19, 2001)]
[Rules and Regulations]
[Pages 15348-15349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 522


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 (NADA's) from Wendt Laboratories, Inc., to 
First Priority, Inc.

DATES: This rule is effective March 19, 2001.

FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION: Wendt Laboratories, Inc., 100 Nancy Dr., 
Belle Plaine, MN 56011, has informed FDA that it has transferred to 
First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, ownership 
of, and all rights and interests in NADA 48-646 for Therazone Injection 
and NADA 48-647 for Therazone Tablets. Accordingly, the agency is 
amending the regulations in 21 CFR 520.1720a and 522.1720 to reflect 
the transfer of ownership.
    In addition, First Priority, Inc., has not been previously listed 
in the animal drug regulations as a sponsor of an approved application. 
At this time, 21 CFR 510.600(c) is being amended to add entries for the 
firm.
    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 522

    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, 
520, and 522 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.


    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``First Priority, Inc.'' and in the 
table in paragraph (c)(2) by numerically adding an entry for ``058829'' 
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
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*                  *                  *                  *
                  *                  *                  *
First Priority, Inc., 1585 Todd      058829
 Farm Dr., Elgin, IL 60123
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
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*                  *                  *                  *
                  *                  *                  *
058829                               First Priority, Inc., 1585 Todd
                                      Farm Dr., Elgin, IL 60123.
 
*                  *                  *                  *
                  *                  *                  *
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[[Page 15349]]

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 ``015579'' and adding in its place 
``058829''.

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

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

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


Sec. 522.1720  [Amended]

    6. Section 522.1720 Phenylbutazone injection is amended in 
paragraph (b)(1) by removing ``015579'' and adding in its place 
``058829''.

    Dated: February 9, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaulation, Center for Veterinary 
Medicine.
[FR Doc. 01-6713 Filed 3-16-01; 8:45 am]
BILLING CODE 4160-01-F