[Federal Register Volume 70, Number 170 (Friday, September 2, 2005)]
[Rules and Regulations]
[Pages 52291-52292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17472]


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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 new 
animal drug application (NADA) from Alpharma Inc., to Pharmaq AS. The 
drug labeler code for Pharmaq AS is also being listed.

DATES: This rule is effective September 2, 2005.

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: 
<a href="/cdn-cgi/l/email-protection#b8dcd9ced1dc96d6ddcfd3d1cad3f8dedcd996dfd7ce"><span class="__cf_email__" data-cfemail="c9ada8bfa0ade7a7acbea2a0bba289afada8e7aea6bf">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Drive, Fort 
Lee, NJ 07024, has informed FDA that it has transferred ownership of, 
and all rights and interest in, NADA 125-933 for ROMET-30 
(sulfadimethoxine/ormetoprim) Type A medicated article to Pharmaq AS, 
Skogmo Industriomrade, N-7863 Overhalla, Norway. Accordingly, the 
agency is amending the regulations in 21 CFR 558.575 to reflect the 
transfer of ownership.
    In addition, Pharmaq AS has not been previously listed in the 
animal drug regulations as a sponsor of an approved application. 
Accordingly, 21 CFR 510.600(c) is being amended to add entries for 
Pharmaq AS.
    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.

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 510 and 
558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
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.

0
2. Section 510.60o is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Pharmaq AS'' and in the table 
in paragraph (c)(2) by numerically adding a new entry for ``015331'' to 
read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Pharmaq AS, Skogmo Industriomrade, N-7863     015331
 Overhalla, Norway.
                                * * * * *
------------------------------------------------------------------------


[[Page 52292]]

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
015331                       Pharmaq AS, Skogmo Industriomrade, N-7863
                              Overhalla, Norway.
                                * * * * *
------------------------------------------------------------------------

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.  558.575  [Amended]

0
4. Section 558.575 is amended in paragraph (a)(2) by removing 
``046573'' and by adding in its place ``No. 015331''.

    Dated: August 22, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-17472 Filed 9-1-05; 8:45 am]
BILLING CODE 4160-01-S


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