[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Rules and Regulations]
[Pages 60551-60552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


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

[[Page 60552]]

animal drug regulations to reflect a change of sponsor for seven 
approved new animal drug applications (NADAs) from Schering-Plough 
Animal Health Corp. 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: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit NJ 07901, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following seven 
approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, 
Bulgaria:

------------------------------------------------------------------------
        Application No.                       Trade name(s)
------------------------------------------------------------------------
140-951                         CLINICOX (diclazuril) Type A Medicated
                                 Article
------------------------------------------------------------------------
141-090                         CLINICOX / STAFAC
------------------------------------------------------------------------
141-153                         CLINICOX / BMD
------------------------------------------------------------------------
141-158                         CLINICOX / FLAVOMYCIN
------------------------------------------------------------------------
141-190                         CLINICOX / BMD / 3-NITRO
------------------------------------------------------------------------
141-194                         CLINICOX / BMD
------------------------------------------------------------------------
141-195                         CLINICOX / FLAVOMYCIN
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
558.198 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.  558.198  [Amended]

0
2. In Sec.  558.198, in paragraph (b), remove ``000061'' and in its 
place add ``016592''; and in the tables in paragraphs (d)(1) and 
(d)(2), in the ``Sponsor'' column, remove ``000061'' wherever it occurs 
and in its place add ``016592''.

    Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21059 Filed 10-24-07; 8:45 am]
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