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[Federal Register: May 2, 2002 (Volume 67, Number 85)]
[Rules and Regulations]               
[Page 21996]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02my02-14]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 
Oral 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 three approved 
abbreviated new animal drug applications (ANADAs) from Blue Ridge 
Pharmaceuticals, Inc., to Virbac AH, Inc.

DATES: This rule is effective May 2, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
<A HREF="mailto:lluther@cvm.fda.gov">lluther@cvm.fda.gov</A>.

SUPPLEMENTARY INFORMATION: Blue Ridge Pharmaceuticals, Inc., 4249-105 
Piedmont Pkwy., Greensboro, NC 27410, has informed FDA that it has 
transferred ownership of, and all rights and interest in, NADA 200-270 
for IVERHART (ivermectin) Tablets, NADA 200-281 for WORMEXX (pyrantel 
pamoate) Chewable Tablets, and NADA 200-302 for IVERHART Plus 
(ivermectin/pyrantel pamoate) Flavored Chewable Tablets to Virbac AH, 
Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137. Accordingly, the agency 
is amending the regulations in 21 CFR 520.1193, 520.1196, and 520.2041 
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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec. 520.1193  [Amended]

    2. Section 520.1193 Ivermectin tablets and chewables is amended in 
paragraph (b)(2) by removing ``065274'' and by adding in its place 
``051311''.


Sec. 520.1196  [Amended]

    3. Section 520.1196 Ivermectin and pyrantel pamoate chewable tablet 
is amended in the section heading by removing ``tablet'' and by adding 
in its place ``tablets''; and in paragraph (b) by removing ``065274'' 
and by adding in its place ``051311''.


Sec. 520.2041  [Amended]

    4. Section 520.2041 Pyrantel pamoate chewable tablets is amended in 
paragraph (b) by removing ``065274'' and by adding in its place 
``051311''.

    Dated: April 3, 2002..
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-10793 Filed 5-1-02; 8:45 am]
BILLING CODE 4160-01-S

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