[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Page 20731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form 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 the change of sponsor for a new animal drug 
application (NADA) from Merial Ltd., to Vetoquinol N.-A., Inc.

DATES: This rule is effective April 18, 2000.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Iseline, NJ 
08830-3077, has informed FDA that it has transferred the ownership of, 
and all rights and interests in, the approved NADA 113-510 
(phenylbutazone granules) to Vetoquinol N.-A., Inc., 2000 chemin 
Georges, Lavaltrie (PQ), Canada, J0K 1H0. Accordingly, the agency is 
amending the regulations in 21 CFR 510.600(c) and 520.1720b(b) to 
reflect the change of sponsor.
    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 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.

    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

    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 ``Vetoquinol N.-A., Inc.,'' and in 
the table in paragraph (c)(2) by numerically adding an entry for 
``059320'' 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
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
Vetoquinol N.-A., Inc., 2000 chemin  059320
 Georges, Lavaltrie (PQ), Canada,
 J0K 1H0
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

    (2) * * *

 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
059320                               Vetoquinol N.-A., Inc., 2000 chemin
                                      Georges, Lavaltrie (PQ), Canada,
                                      J0K 1H0
  *                    *                    *                    *
                   *                    *                    *
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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. 520.1720b  [Amended]

    4. Section 520.1720b Phenylbutazone granules is amended in 
paragraph (b) by removing ``050604'' and by adding in its place 
``059320''.

    Dated: March 17, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-9573 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F