[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) * * *
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Firm name and address Drug labeler code
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* * * *
* * *
Veterinary Research Associates, 064408
Inc., 20 Old Dock Rd., Yaphank, NY
11980
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
064408 Veterinary Research Associates,
Inc., 20 Old Dock Rd., Yaphank, NY
11980
* * * *
* * *
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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
