[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Page 45878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable 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 a change of sponsor for an approved new 
animal drug application (NADA) from Heska Corp. to Pharmacia & Upjohn 
Co.

DATES: This rule is effective July 26, 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: Heska Corp., 1825 Sharp Point Dr., Fort 
Collins, CO 80525, has informed FDA that it has transferred to 
Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199 
ownership of, and all rights and interests in NADA 141-082. 
Accordingly, the agency is amending the regulations in 21 CFR 522.778 
to reflect the transfer of ownership.
    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 in 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 part 522 is 
amended as follows:

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

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

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

Sec. 522.778  [Amended]

    2. Section 522.778 Doxycycline hyclate is amended in paragraph (b) 
by removing ``063604'' and adding in its place ``000009''.

    Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-18825 Filed 7-25-00; 8:45 am]
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