[Federal Register Volume 69, Number 208 (Thursday, October 28, 2004)]
[Rules and Regulations]
[Pages 62810-62811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24112]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for three new animal 
drug applications (NADAs) from Sweetlix LLC to Ridley U.S. Holdings, 
Inc.

DATES: This rule is effective October 28, 2004.

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: Sweetlix LLC, 175 South Main St., suite 150, 
Salt Lake City, UT 84111, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following three 
approved NADAs to Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., 
P.O. Box 8500, Mankato, MN 56002-8500:

----------------------------------------------------------------------------------------------------------------
         Application Number                      21 CFR Section                          Trade Name
----------------------------------------------------------------------------------------------------------------
NADA 033-733                          520.1840                              Sweetlix Bloat Guard Block
----------------------------------------------------------------------------------------------------------------

[[Page 62811]]

 
NADA 109-471                          520.1448a                             Cattle Block M
----------------------------------------------------------------------------------------------------------------
NADA 136-214                          520.1846                              Enproal Bloat Blox
----------------------------------------------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.1448a, 520.1840, and 520.1846 to reflect the transfer of ownership.
    Following these changes of sponsorship, Sweetlix LLC is no longer 
the sponsor of an approved application. In addition, Ridley U.S. 
Holdings, Inc., is not currently listed in the animal drug regulations 
as a sponsor of an approved application. Accordingly, Sec.  510.600(c) 
is being amended to remove the entries for Sweetlix LLC and to add 
entries for Ridley U.S. Holdings, Inc.
    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 520

    Animal drugs.

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 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR parts 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entry for ``Sweetlix LLC'' and by alphabetically adding an 
entry for ``Ridley U.S. Holdings, Inc.'' and in the table in paragraph 
(c)(2) by removing the entry for ``036904'' and by adding an entry for 
``067949'' 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
------------------------------------------------------------------------
                                * * * * *
Ridley U.S. Holdings, Inc., 424 North         067949
 Riverfront Dr., P.O. Box 8500, Mankato, MN
 56002-8500.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
067949                       Ridley U.S. Holdings, Inc., 424 N.
                              Riverfront Dr., P.O. Box 8500, Mankato, MN
                              56002-8500
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.1448a  [Amended]

0
4. Section 520.1448a is amended in paragraph (a)(2) by removing 
``036904'' and by adding in its place ``No. 067949.''


Sec.  520.1840  [Amended]

0
5. Section 520.1840 is amended in paragraph (b)(3) by removing 
``036904'' and by adding in its place ``067949.''


Sec.  520.1846  [Amended]

0
6. Section 520.1846 is amended in paragraph (b) by removing ``050112'' 
and by adding in its place ``067949.''

    Dated: October 20, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-24112 Filed 10-27-04; 8:45 am]
BILLING CODE 4160-01-S