[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Rules and Regulations]
[Page 51080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


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 
abbreviated new animal drug application (ANADA) from Equi Aid Products, 
Inc., to Farnam Companies, Inc.

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

SUPPLEMENTARY INFORMATION: Equi Aid Products, Inc., 1517 West Knudsen 
Dr., Phoenix, AZ 85027, has informed FDA that it has transferred 
ownership of, and all rights and interest in, ANADA 200-168 for CW 48 
(pyrantel tartrate) Type A medicated article to Farnam Companies, Inc., 
301 West Osborn, Phoenix, AZ 85013-3928. Accordingly, the agency is 
amending the regulations in Sec. 558.485 (21 CFR 558.485) to reflect 
the transfer of ownership.
    Following this change of sponsorship, Equi Aid Products, Inc., is 
no longer the sponsor of any approved application. Accordingly, 
Sec. 510.600(c) is amended to remove the entries for Equi Aid Products, 
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 558

    Animal drugs, Animal feeds.

    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 
558 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 ``Equi Aid Products, Inc.'' and in the 
table in paragraph (c)(2) by removing the entry for ``062240''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.485  [Amended]

    4. Section 558.485 Pyrantel tartrate is amended in paragraph (b)(7) 
by removing ``, 017135, and 062240'' and by adding in its place ``and 
017135''.

    Dated: July 17, 2002.
Alan Rudman,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-19861 Filed 8-6-02; 8:45 am]
BILLING CODE 4160-01-S