[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Rules and Regulations]
[Page 60551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21057]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 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 five approved new 
animal drug applications (NADAs) from Merial Ltd., to Huvepharma AD.

DATES: This rule is effective October 25, 2007.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

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 five 
approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, 
Bulgaria:

 
------------------------------------------------------------------------
        Application No.                       Trade name(s)
------------------------------------------------------------------------
012-350                          AMPROVINE (amprolium) 25% Type A
                                  Medicated Article; CORID (amprolium)
                                  25% Type A Medicated Article
------------------------------------------------------------------------
013-149                          AMPROVINE (amprolium) 9.6% Solution
------------------------------------------------------------------------
013-461                          Broiler PMX No. 1620 (amprolium/
                                  ethopabate)
------------------------------------------------------------------------
033-165                          AMPROVINE (amprolium) 20% Soluble
                                  Powder; CORID (amprolium) 20% Soluble
                                  Powder
------------------------------------------------------------------------
034-393                          COYDEN 25 (clopidol); Lerbek 25
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.100, 558.55, 558.58, and 558.175 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

21 CFR Part 520

    Animal drugs.

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 parts 520 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.100  [Amended]

0
2. In paragraph (b)(1) of Sec.  520.100, remove ``050604'' and in its 
place add ``016592''.

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

0
3. 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
4. In paragraph (a) of Sec.  558.55, remove ``050604'' and in its place 
add ``No. 016592''.

0
5. In Sec.  558.58, in the table in paragraph (e)(1)(i), in the first 
entry, in the ``Sponsor'' column, add ``050604'' and ``016592''; add 
paragraph (a)(3); and revise paragraph (b) to read as follows:


Sec.  558.58  Amprolium and ethopabate.

    (a) * * *
    (3) 25 percent amprolium and 0.8 percent ethopabate.
    (b) Approvals. See Sec.  510.600(c) of this chapter.
    (1) No. 050604 for products described in paragraph (a) of this 
section.
    (2) No. 016592 for product described in paragraph (a)(3) of this 
section.


Sec.  558.175  [Amended]

0
6. In Sec.  558.175, in paragraph (b) and in the table in paragraph 
(d)(1) in the ``Sponsor'' column, remove ``050604'' and in its place 
add ``016592''.

    Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21057 Filed 10-24-07; 8:45 am]
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