Document ID: FDA-2009-N-0665-0063
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds; Change of Sponsor
Posted Date: 2009-11-23T05:00Z

[Federal Register: November 23, 2009 (Volume 74, Number 224)]
[Rules and Regulations]               
[Page 61028-61029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no09-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs for Use in Animal Feeds; 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 10 new animal drug 
applications (NADAs) from Merial Ltd. to Huvepharma AD.

DATES: This rule is effective November 23, 2009.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following 10 approved 
NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria: 
NADA 036-304, 049-179, 049-180, 118-507, 040-264, 041-541, 044-016, 
046-209, 049-934, and 099-150. Accordingly, the agency is amending the 
regulations 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 558

    Animal drugs, Animal feeds.

0
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 558 is 
amended as follows:

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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.55  [Amended]

0
2. In Sec.  558.55, in paragraph (d)(2)(iv), in the table, in the entry 
for ``Carbarsone 227 to 340.5'', in the ``Sponsor'' column, remove 
``000006'' and in its place add ``016592''.

0
3. Amend Sec.  558.58 as follows:
    a. Remove paragraphs (a)(3), (b)(1), and (b)(2);
    b. In paragraph (e)(1)(i), in the table, in the ``Sponsor'' column, 
remove ``050604'';
    c. In paragraphs (e)(1)(ii) and (e)(1)(iii), in the table, in the 
``Limitations'' column, remove ``050604'' wherever it occurs and in its 
place add ``016592''; and
    d. Revise paragraph (b).
    The revisions are to read as follows:

Sec.  558.58  Amprolium and ethopabate.

* * * * *
    (b) Approvals. See No. 016592 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  558.175  [Amended]

0
4. In Sec.  558.175, in paragraph (b) and in the table in paragraph 
(d), in the ``Sponsor'' column, remove ``050604'' wherever it occurs 
and in its place add ``016592''.

[[Page 61029]]

    Dated: November 16, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-28009 Filed 11-20-09; 8:45 am]

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