[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Rules and Regulations]
[Pages 51079-51080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19862]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529


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 DEC International, Inc., to 
Pharmacia & Upjohn Co.

DATES: This rule is effective August 7, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 
Standish Pl.,

[[Page 51080]]

Rockville, MD 20855, 301-827-0209, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: DEC International, Inc., 1919 South 
Stoughton Rd., P.O. Box 8050, Madison WI 53708-8050, has informed FDA 
that it has transferred ownership of, and all rights and interests in, 
NADA 141-200 for EAZI-BREED CIDR Progesterone Intravaginal Inserts to 
Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199. 
Accordingly, the agency is amending the regulations in 21 CFR 529.1940 
to reflect the transfer of ownership.
    Following this change of sponsorship, DEC International, Inc., is 
no longer the sponsor of any approved application. Accordingly, 21 CFR 
510.600(c) is being amended to remove the entries for DEC 
International, Inc.
    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 Part 529

    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 
529 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.


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``DEC International, Inc.'' and in the 
table in paragraph (c)(2) by removing the entry for ``067080''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec. 529.1940  [Amended]

    4. Section 529.1940 Progesterone intravaginal inserts is amended in 
paragraph (b) by removing ``067080'' and by adding in its place 
``000009''.

    Dated: July 17, 2002.
Alan Rudman,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-19862 Filed 8-6-02; 8:45 am]
BILLING CODE 4160-01-S