[Federal Register Volume 63, Number 228 (Friday, November 27, 1998)]
[Rules and Regulations]
[Pages 65552-65553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 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 the change of sponsor for one approved 
abbreviated new animal drug application (ANADA) from American 
Veterinary Products, Inc., to Veterinary Research Associates, Inc.

EFFECTIVE DATE:  November 27, 1998.

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:  American Veterinary Products, Inc., 749 
South Lemay, suite A3-231, Fort Collins, CO 80524, has informed FDA 
that it has transferred the ownership of, and all rights and interests 
in, the approved ANADA 200-073 (ketamine hydrochloride) to Veterinary 
Research Associates, Inc., 20 Old Dock Rd., Yaphank, NY 11980. 
Accordingly, the agency is amending the regulations in 21 CFR 
522.1222a. The agency is also amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) by removing American Veterinary Products, 
Inc., because the firm is no longer the sponsor of any approved 
ANADA's, and by alphabetically adding a new listing for Veterinary 
Research Associates, Inc.

[[Page 65553]]

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 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 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 
removing the entry for ``American Veterinary Products, Inc.,'' and by 
alphabetically adding an entry for ``Veterinary Research Associates, 
Inc.,'' and in the table in paragraph (c)(2) by removing the entry for 
``045984'' and by numerically adding an entry for ``064408'' 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
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
Veterinary Research Associates,      064408
 Inc., 20 Old Dock Rd., Yaphank, NY
 11980
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

    (2) * * *

 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
064408                               Veterinary Research Associates,
                                      Inc., 20 Old Dock Rd., Yaphank, NY
                                      11980
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

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

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

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

Sec. 522.1222a  [Amended]

    4. Section 522.1222a Ketamine hydrochloride injection is amended in 
paragraph (c) by removing the phrase ``045984, 059130, and 061690'' and 
adding in its place ``059130, 061690, and 064408''.

    Dated: October 29, 1998.
 Margaret Ann Miller,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-31574 Filed 11-25-98; 8:45 am]
BILLING CODE 4160-01-F